This HPLC calibration Standard Operating Procedure (SOP) describes all the individual steps necessary for calibrating a HPLC in accordance with cGMP (current good manufacturing practices). As for any calibration in the pharmaceutical environment, the calibration of the HPLC also needs to be described in a procedure and followed by the analyst in line with regulations. To avoid getting cited e.g. by the FDA with a 483 for not having documentation regarding calibration for a HPLC in the Quality control laboratories or not having acceptance criteria or the interval of calibration set prior conduct.

This Standard Operating Procedure (SOP) details all the necessary individual steps involved in the HPLC calibration.

All necessary documentation requirements are listed on 22 pages Standard Operating Procedure (SOP) and its corresponding 8 attachments. This SOP template is ready to use and needs only a small amount of site-specific modification.

Pharmaceutical companies recognise that an efficient change control system is the only way to ensure they can rapidly adjust systems and processes so as to stay competitive and continually improve effectiveness and quality. Managing changes will have a major impact on any company’s future success. 

This Standard Operating Procedure (SOP) will help you simplify change control and documentation by putting in place a powerful and extremely effective change control system. It does this by acknowledging: CFR 314.70 “Supplements and other changes to an approved application”, Commission Regulation EC 541/95 “Variation to the terms of a marketing authorization”, ISO 9004, 08.8 Design Change Control, 11.6 Process Change Control, PIC – PH 1/96 and ICH Q7A chapter 13 ‘Change Control’. 

This Standard Operating Procedure (SOP) describes the change control process flow in detail, starting with a change request then following the necessary assessments and approvals. This standard process ensures that all planned changes affecting any aspect of manufacturing, testing and distribution are reviewed, assessed and approved by technical and quality-competent site personnel, including the quality assurance department. 

The main task in Change Control is to evaluate potential impacts and any related consequences in terms of product quality, safety and Good Manufacturing Practice (GMP). The qualification and validation statuses as well as the official registration must be checked before a change can be implemented. 

This 8-page SOP, which includes a Change Control Form, is ready to use and only needs a small amount of site-specific modification before it can be adopted for your operations.

The purpose of this Standard Operating Procedure (SOP) is to define the content and formal aspects of equipment logbooks. All companies are required to keep a logbook for the chronological documentation of equipment-related events such as validation and qualification work, calibration, equipment cleaning, preventive maintenance and repairs and unexpected events/deviations for manufacturing equipment, apparatus, quality control and IPC analytical equipment and utilities.

This Standard Operating Procedure (SOP) regulates responsibilities and describes the procedure for creating and managing logbooks and registering entries.

Governmental agencies in the pharmaceutical sector, such as the FDA, are challenging companies on an increasingly regular basis as regards their corrective and preventive action (CAPA) systems. Their aim is to ensure that deviations/non-conformance, product complaints, external and internal audit observations, annual product reviews, recommendations and regulatory issues are identified, fully investigated to their root cause and properly assessed.

This Standard Operating Procedure (SOP) is ready to use and meets all the expectations of cGMP agencies as regards CAPA systems. The 6-page SOP, which includes 2 attachments, needs only site-specific modification before it can be used for your operations.

Products on the market that are suspected or known to be seriously defective and/or pose a potential risk to patient health must be recalled. This must be done promptly, comprehensively and in accordance with any governmental health agency regulations and requirements governing distributed products.
This applies to all products manufactured and distributed from a site, including physician samples and commercial products used for market studies and clinical trials.

This 11-page SOP (Standard Operating Procedure)applies to all drug product and device manufacturers and describes the roles and responsibilities of the Recall Coordinator and the Recall Committee, as well as the order of events. It also includes 1 attachment - the recall decision flow chart.

This calibration Standard Operating Procedure (SOP) describes all the individual steps necessary for calibrating dissolution test apparatus type 1 (basket apparatus) and type 2 (paddle apparatus) in accordance with USP requirements and cGMP (current good manufacturing practices). As for any calibration in the pharmaceutical environment, the calibration of dissolution test apparatus also needs to be described in a procedure and followed by the analyst in line with regulations in the US Pharmacopeia under General Chapters <711> Dissolution. 

This Standard Operating Procedure (SOP) details the individual steps involved in calibration with USP disintegrating tablets (Prednisone) and non-disintegrating tablets (salicylic acid). This includes, but is not limited to, calibration of the rotation and wobble of the dissolution spindle. 

All necessary documentation requirements are listed in this Standard Operating Procedure (SOP) and its corresponding attachments. Both methods - Apparatus 1 (baskets) or Apparatus 2 (paddles) - and a combination of the two are described on 12 pages, including a 3-page protocol attached to the SOP. This SOP template is ready to use and needs only a small amount of site-specific modification.

An annual product review (APR) should be conducted for every commercial product. The purpose of this review is to verify the consistency of the manufacturing process, assess trends, determine the needs for changes in specifications, production, manufacturing and/or control procedures and evaluate the needs for revalidation. 

This APR is reported and approved in a product-specific annual product review report. Our 8-page APR SOP summarises FDA CFR expectations and PIC guidance. It also includes a 6-page, ready-to-use APR template. The SOP and template only need a small amount of site-specific modification before they can be adopted for your operations.

The preventive maintenance program was and still is a focal point of GMP inspection. Agencies have realised that the preventive maintenance program is a crucial component of any modern quality system because it ensures efficient GMP operations.

The purpose of this Standard Operating Procedure (SOP) is to describe the procedures involved in commissioning, conducting and managing a site's preventive maintenance (PM) activities. This Standard Operating Procedure (SOP) applies to work within GMP and non-GMP areas where PM is scheduled. This includes work that is related to environment health & safety regulatory requirements. This Standard Operating Procedure (SOP) also applies to all employees responsible for any type of preventive maintenance for instrumentation, equipment and utilities. 

It needs only a small amount of site-specific modification before it can be adopted to ensure an effective preventive maintenance program. The SOP can be used in the area of drug, drug substance, medical device and biotech manufacturing and contains 8 pages, including 2 attachments.

A site’s pest control program should monitor pests to ensure that they are kept safely and effectively under control. This Standard Operating Procedure (SOP) was written to define the procedures and responsibilities of a site’s pest control program, which include planning and implementation, as well as monitoring the efficiency of the program by carrying out regular reviews of collected pest data. The pest control program encompasses all manufacturing, storage and distribution areas.

This Standard Operating Procedure (SOP) can be applied to all pharmaceutical GMP-regulated operations such as drug product, active pharmaceutical ingredient, excipient, vaccine and device manufacturing. The 6-page SOP includes an appendix indicating the locations of pest traps on a site map.

Pre-Inspection Activities - This section will help you to understand why the Pre Inspection Activities will be the crucial factor to successfully pass a Pre Approval Inspection.

During the Inspection - This section shows how closely success or failure is linked with the skills and capabilities of the personnel fronted to an inspector and the importance of a perfect backroom organization.

The Exit Meeting - This section will give a brief description of a standard PAI exit meeting held on the last day including some advise on correct attitude and reaction.

Post-Inspection Activities - This section provides guidance on how to react to Inspector’s citation including time proposal and some further recommendations for the post inspection activities.

Regular supplier audits must be performed to assess the effectiveness of suppliers’ quality assurance systems and to ensure that suppliers meet the requirements of cGMP. The comprehensive testing of pharmaceutical goods is no substitute for an efficient site supplier audit program.

This Standard Operating Procedure (SOP) deals with suppliers involved in activities such as contract manufacturing, packaging/labelling operations, analytical/microbiological laboratory testing, stability testing and general cGMP facilities.

The 16-page Standard Operating Procedure (SOP) guides you step by step through the essential key processes of pre-audit activities, the audit itself and post-audit activities. It describes the responsibilities of the lead auditor, the audit team and the party subject to the audit and also includes a general audit scheme quoted directly from the “Food and Drug Administration Compliance Program Guidance Manual Program”.

Attached to the Standard Operating Procedure (SOP) is an audit report form reflecting all the details needed for a common industry audit report. This SOP template only needs a small amount of site-specific modification before it can be adopted for your operations.

The aim of the supplier certification program is, firstly, to ensure that all products and services necessary for GMP operations consistently meet your acceptance criteria and, secondly, to enable you to implement a reduced testing regime for incoming goods. This Standard Operating Procedure (SOP) is applicable for all suppliers that provide raw materials, intermediates, packaging materials and components that are subject to GMP manufacturing processes. 

Using a step-by-step approach, this procedure describes all the measures that need to be taken to certify a supplier. This Standard Operating Procedure (SOP) covers all key processes in supplier certification, starting with supplier approval, then subsequent steps toward becoming a qualified supplier and, finally, achieving certified status. This supplier certification program will result in increased customer satisfaction, accurate and up-to-date supplier records, a better understanding of your partners, mutually beneficial partnerships and improved product and service quality. 

The 8-page SOP, which includes two attachments – a supplier status list and a supplier qualification change control sheet – is ready to use and only needs a small amount of site-specific modification.

Good manufacturing practice (GMP) regulations require that all documentation be issued, managed and controlled using a document management system.

This 11-page Standard Operating Procedure (SOP) describes the procedures for completing all GMP-relevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution and archiving. This SOP will guide you through the process of setting up a new GMP document management system and help you to optimise an existing document management system.

Failure to identify and correct the root cause of deviations continues to be a major concern for regulatory agencies. Regulatory bodies expect companies to quickly identify, fully investigate and properly analyse and document deviations and unplanned quality incidents. 

This 12-page Standard Operating Procedure (SOP) will guide you step by step through this process, helping ensure that deviations are investigated within 30 working days, that all investigations are fully documented and analysed by the responsible line units and quality assurance, that corrective measures are implemented if applicable, that implementation is tracked and that the entire process is managed, monitored and controlled. 

This Standard Operating Procedure (SOP) is applicable for industries dealing with drug products, drug substances, medical devices and biotech products. The SOP needs only a small amount of site-specific modification before it can be adopted for your own operations.

The proper usage, calibration and maintenance of any analytical balances is a crucial important prerequisite following GMP compliance to generate meaningful analytical results. In the past but also today it is still a major area which will be visited during FDA inspections, which includes the weighing practices as such as well as the SOP describing these steps. On 11 pages this SOP (Standard Operating Procedure) guides you trough these processes and gives you in addition general GMP prerequisites to assure that Quality Control personnel performs the preparation, weighing, calibration and maintenance steps in accordance with the cGMPs. This SOP basically gives you all the necessary GMP guidance you need and can be used with only little company specific adoption.

Insufficient customer complaint handling was, and still is, one of FDA’s top findings in warning letters published under the FDA’s freedom of information legislation. In addition, the FDA starts to review not only US-related customer complaints for products on the US market but since the New Quality System Approach has been used during inspections, complaints for non-US products may also be investigated to challenge the companies complaint system.

This Standard Operating Procedure (SOP), including an investigation form attached, guides you step-by-step through the process of investigating, documenting, reporting and following up customer complaints. The responsibilities for the complaint investigations are also clearly defined in this SOP, which is a crucial prerequisite for any functional system. This Standard Operating Procedure (SOP) only needs a small amount of site-specific modification before it can be adopted for your operations.

A main GMP requirement for GMP regulated active pharmaceutical ingredients (APIs) and drug products (DPs) is the need of a written stability program / plan.
The results of the stability testing are to be used in determining appropriate storage conditions and a product's expiration date. The WHO as well as the ICH have issued various guidelines for stability testing of marketed pharmaceutical products, products under development and stability testing of new Drug Substances (APIs).
The purpose of a stability testing program is to establish a re-test and to define storage conditions that could influence the quality of a drug substance or drug product depending on a variety of environmental factors such as temperature, humidity, and light.
This Standard Operating Procedure (SOP) / Stability Study Program (Plan) will certainly help you to set up a concurrent Study Plan and Protocol in compliance with regulatory expectations. This procedure is applicable to drug substances and drug products.
This Standard Operating Procedure / Stability Study Program (Plan) consist out of 29 pages including 5 attachments and need only a little amount of company-specific modification before it can be used.

Training is considered an essential tool for human resources management and for ensuring the workforce is appropriately qualified to perform its duties. This Standard Operating Procedure (SOP) covers the training skills level required of site personnel (including temporary personnel) who perform skilled functions (i.e. GMP, etc.) where product quality and the quality system itself could be adversely affected by a lack of appropriate skills.

This Standard Operating Procedure (SOP) was written to incorporate all comprehensive training activities into one system to ensure that all personnel acquire the skills, knowledge and qualifications needed to effectively carry out their duties and tasks. This SOP (Standard Operating Procedure) can be applied to all pharmaceutical GMP-regulated areas such as drug products, active pharmaceutical ingredients, excipients, vaccines and medical devices. This 15-page SOP includes 5 attachments: an on-the-job training form, a training needs analysis form, a course evaluation form, an attendance register form and a training course attendance request form.

This ready-to-use 21 CFR 820 quality audit questionnaire (audit by mail) has been created for the assessment of potential device suppliers that need to comply with the US FDA regulatory requirements set out in 21 CFR 820. The checklist will help you evaluate potential suppliers and cut costs and outlay. This 26-page checklist covers all sections of 21 CFR 820. It can also be used as an inspection checklist for internal or external audits.

The FDA considers the integrity of laboratory testing documentation records to be of fundamental importance during drug manufacturing. As a drug manufacturer, you must ensure that your laboratory-based investigation of failures (OOS results and confirmed OOS results) is carried out without compromising product quality or current authority expectations.

This Standard Operating Procedure (SOP) (13 pages plus attachment) guides you step by step through the process of investigating and documenting OOS results. It describes the responsibilities of laboratory personnel, QC supervisors and QA managers. Attached to the SOP is an easily understandable form that reflects the OOS process. The form divides relevant data and assessments into three logical sections: the preliminary assessment, the investigation plan and results and the final approval. This Standard Operating Procedure (SOP) only needs a small amount of site-specific modification before it can be adopted for your operations.

This Standard Operating Procedure (SOP) is applicable to the chemicals, reagents and solutions used in analytical testing designed to define and standardise labelling and handling procedures in laboratories. The appropriate handling of chemicals, reagents and solutions and the process of assigning them a reasonable shelf life are key procedures in the quality laboratory that ensure the validity of all analytical results. During inspections, inspectors expect quality laboratories to have sound procedures and controls in place.

This Standard Operating Procedure (SOP) only needs a small amount of site-specific modification before it can be adopted for your operations.

A robust calibration program is the basis for all operations associated with any quality-related measurement. The calibration program is one of the key quality systems for successful GMP operations as well as for ensuring compliance during regulatory inspections. The calibration system as laid out in 21 CFR 211.68 is mandatory for automatic, mechanical, and electronic equipment. However, the calibration program is not a stand-alone program but rather an interface between the calibration department, metrologists, equipment users and the quality assurance department. The effectiveness of this program relies on cooperation among these groups.

This SOP (Standard Operating Procedure) sets out the responsibilities of all involved parties in an unambiguous manner and defines the main processes of the calibration program. The SOP (Standard Operating Procedure) only needs a small amount of site-specific modification before an effective calibration program can be implemented. The SOP can be used in the area of drug, drug substance, medical device and biotech manufacturing and contains 12 pages, including 2 attachments.

From both a regulatory and commercial perspective, companies should work with their suppliers (contract manufacturers) to ensure that they receive materials and services in line with predetermined specifications covering quality, volume and delivery. Some companies limit the Supplier Qualification process to the creation of a supplier contract. However, this approach is usually insufficient when it comes to specifying the tasks, responsibilities and duties of each party as regards product quality and testing.

“Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. […] The contract must clearly state the way in which the Qualified Person releasing each batch of product for sale exercises his full responsibility” (extract from the Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Chapter 7, Contract Manufacture and Analysis).

This master document template for technical quality contract manufacturing, which is over 35 pages in length, clearly defines the duties of the Contract Giver and the Contract Acceptor and is extremely beneficial for both parties. The template specifies all the arrangements, agreements and controls needed to avoid misunderstandings that could result in a product or work of unsatisfactory quality.

It includes nine attachments that cover the details of processes, materials, IPC, product specifications, stability, customers and labels. This ready-to-use template only needs a small amount of site-specific modification before you can adopt it in its entirety for your operations. All you need to do is enter your site-specific information in the coloured fields that are marked.

The drug product SITE MASTER FILE (SMF) is the site’s most important GMP document and provides a general overview of the site and its operations. On 5 November 2002, the guidelines for the preparation of a SITE MASTER FILE (first edition, April 2000) were replaced by the PIC/S explanatory notes for industry on the preparation of a site master file, 1 November 2002.

This SITE MASTER FILE has been created in line with current industry standards and is based on guidance from both the European Commission Directorate General III – “Industry” Harmonisation of Inspections in the EU and PIC recommendations.

Running to over 30 pages, this SITE MASTER FILE template only needs a small amount of site-specific modification before it can be adopted for your operations. All you need to do is enter your site-specific information in the coloured fields that are marked.

It covers the pharmaceutical production facility, which incorporates a wide variety of manufacturing technologies. The SMF template includes all necessary information for the manufacturing of tablets, coated tablets, capsules, ointments, creams, gels, suppositories, suspensions, syrups, inhalers, ampoules, vials and syringes.

“Failure to ensure that reprocessed batches of product will conform with all established standards, specifications, and characteristics [21 CFR 211.115(a)] in that there were no written procedures and validation data that support the reprocessing and reworking of products.” This is an FDA 483 observation that could have been avoided by having an internal procedure (SOP) in place that contains clear guidance on the steps that need to be taken before performing reprocessing or reworking.

This Standard Operating Procedure (SOP) is based on Q7A Section XIV, CFR211.115 (a) and (b) and the applicable guidance documents and provides clear and concise guidance for the important steps involved. It also clearly defines the responsibilities for reprocessing and/or reworking investigations, which is a crucial prerequisite for any functional system. This 10-page Standard Operating Procedure (SOP) only needs a small amount of site-specific modification before you can adopt it for your operations.

A self-inspection program, which can be applied to all GMP-regulated pharmaceutical areas (drug products, active pharmaceutical ingredients and devices), should encompass all current good pharmaceutical manufacturing practices (cGMP). It is an effective and powerful tool for ensuring compliance with relevant GMP and regulatory requirements.

The self-inspection program should be implemented to identify non-conformance and to resolve this by defining and monitoring appropriate corrective measures. Non-conformance should be rated according to how critical it is and resolved through corrective and preventive action (CAPA) to ensure the continuous improvement of all quality-related operations and systems.

This 12-page Standard Operating Procedure (SOP) also defines the procedures and responsibilities for self-inspection planning, implementation and follow-up to ensure compliance with regulatory, cGMP and internal quality procedures. Three templates are included: a self-inspection schedule for the year, a self-inspection summary report and a self-inspection issue report.

This FDA field alert Standard Operating Procedure (SOP) is an essential prerequisite when operating on and supplying the U.S. market with pharmaceutical products.

The Standard Operating Procedure (SOP) describes how and when a field alert should be raised with the Food and Drug Administration. The SOP systematically describes the reporting period of 3 working days and other key elements of the FDA’s field alert system. Non-executed or improperly executed field alerts can cause major problems with the FDA, particularly during your next FDA inspection for example. There is a long history of FDA warning letters that address failures to meet the agency’s expectations.

This 12-page Standard Operating Procedure (SOP) includes 2 attachments, the FDA 3321- field alert report form and a 4-page PDF copy of the FDA SOP for handling NDA/ANDA field alert reports. The SOP needs only site-specific modification before it can be used for your operations.

This checklist will enable you to systematically assess the strengths and weaknesses of a computerised system validation using a uniform approach. A scoring option is included which enables you to compare different systems and helps you to judge the compliance status of these systems. The checklist, which contains more than 80 questions, can be used to evaluate potential validation contract vendors/suppliers (front cover letter included). This checklist was created in line with regulatory requirements such as FDA 21 CFR Part 211.68 Automatic, mechanical and electronic equipment, modified FDA 21 CFR Part 11 Electronic records and electronic signatures, FDA Guidance for industry: Computerised systems used in clinical trails, European Guide to Good Manufacturing Practice (1992) Annex 11 Computerized Systems, PIC PH 1/97 Guide to Good Manufacturing Practice for Medicinal Products (Feb. 1997) Annex 5 Computerised Systems, the Blue Book (FDA), PIC/S Guide to Inspection of Computerised Systems, the APV Guide to Annex 11 (EU), GAMP Guide to Validation (EU and FDA) and PDA Technical Report 18 (FDA).

More than 40 pages in length, this self-explanatory PAI protocol for API guides you through the entire PAI preparation process. Similar to the PAI Protocol for DPs, it focuses solely on the specific circumstances of API producers.

Good GMP aseptic technique of personnel is a key prerequisite for GMP compliance and generating meaningful results when working under a clean bench. Also it is a persistent FDA area of concern when performing Inspections, in particular when it comes to the SOPs describing the techniques for operators working under GMP conditions in such an environment.

On only 6 pages this Standard Operating Procedure gives you general GMP guidance for personnel performing aseptic operations under a laminar flow hood, clean bench, or other such clean enclosure. This SOP basically gives you all the necessary GMP guidance you need and can be used with only little company specific adoption.

Comprehensible, detailed and straightforward Standard Operating Procedures (SOPs) are required for successful GMP operations. These SOPs must be written, approved and followed to ensure the consistent application of any routine operation, activity or task that may impact on the safety, quality, purity, efficacy or distribution of an active pharmaceutical ingredient, pharmaceutical product (i.e. drug product) or medical device.

The purpose of this “SOP for SOPs” is to define, standardise and systematise the content, creation, revision, approval and issuing of all standard operating procedures, which includes the definition of roles and responsibilities during this process.

The 9-page “SOP for SOPs” illustrates the key points of the reviewing, issuing and approval process in a process flow diagram. This will help you to set up your SOPs for the first time or improve your existing system and harmonise your SOPs.

The aim of the Hosting Regulatory Inspections program is, firstly, to ensure that a well defined and professional inspection process during FDA or any other regulatory Inspection in connection with pharmaceutical development, manufacturing, testing of materials products or medical devices at your site.

This is a must and also crucial prerequisite for a successful outcome of the authority inspection. This Standard Operating Procedure (SOP) provides all information that should be considered during a regulatory inspection. The SOP covers the whole inspection, starting with the arrival of the investigators/inspectors on site, following the inspection activities and ends with the final close out meeting of the inspection.

The SOP gives also an overview about the organization of the inspection team and the roles and responsibilities of the involved site personnel like Inspection Coordinator, Scribe, Runner and Subject Matter Expert. This 18-page SOP, which includes four attachments – is ready to use and only needs small site specific adoption.

The principles of GLP (Good Laboratory Practice) should be applied in laboratories conducting safety and pre-clinical studies.
They are describing a set of rules and basic requirements for a quality assurance system for non-clinical and environmental safety studies, specifically focusing on how to plan, to perform and to monitor GLP studies and how to report and to archive resulting data.
The GLP principles have been established to assure the quality, validity and reliability of generated test data of chemicals in order to protect human health and environment.
The purpose of General Rules for Laboratories operating under Good Laboratory Practice (GLP) is to define the basic requirements and systems for a GLP Laboratory.
The Guideline contains 17 pages that need only a little amount of company-specific modification before it can be adopted to ensure that your operations are in compliant with GLP.

It is essential to define the management of returned products that are sent back to the initial distributor for any reason whatsoever. These returns must be carefully analysed prior to any salvaging, redistribution or disposal because goods that have left the control of the warehouse should only be returned to saleable stock if they are proven to meet the product’s appropriate standards of safety, identity, strength, quality and purity.

The purpose of this Standard Operating Procedure (SOP) is to describe the site’s roles and responsibilities and the order of events for goods returned from the market to the warehouse. This 9-page Standard Operating Procedure (SOP) includes 2 attachments: an investigation form for returned goods and a returned-goods process flow diagram.

The active pharmaceutical ingredient (API) SITE MASTER FILE (SMF) provides a general overview of the site and its operations. A SITE MASTER FILE is prepared by the manufacturer and contains specific and factual GMP information about the production and/or control of API manufacturing operations at the named site and any closely integrated operations in adjacent and nearby buildings. On 5 November 2002, the guidelines for the preparation of a SITE MASTER FILE (first edition, April 2000) were replaced by the PIC/S explanatory notes for industry on the preparation of a site master file, 1 November 2002.

This SITE MASTER FILE has been created in line with current industry standards and is based on guidance from both the European Commission Directorate General III – “Industry” Harmonisation of Inspections in the EU and PIC recommendations.

The 29-page SITE MASTER FILE template only needs a small amount of site-specific modification before it can be adopted in its entirety for your operations. All you need to do is enter your site-specific information in the coloured fields that are marked.

Le DOSSIER –MAITRE SITE d’un médicament (DMS) est le document BPF le plus important pour un site. Il donne une vision générale du site et des opérations qui y sont mises en œuvre. A partir du 5 novembre 2002, les Recommandations pour la Préparation d’un DOSSIER –MAITRE SITE (première édition, Avril 2000) ont été remplacées par les Notes Explicatives PIC/S pour l’industrie concernant la préparation d’un Dossier-Maître Site, 1er novembre 2002. Ce Dossier-Maître Site créé en fonction des standards industriels actuels se fonde sur le Guide du Directoire Général III de la Commission Européenne – Harmonisation des inspections pour l’« Industrie » dans la communauté européenne, de même que sur les recommandations PIC.



Ces plus de 30 pages contenant un modèle de Dossier-Maître Site ne requièrent que peu de modifications, en ajoutant des informations spécifiques au site, avant que vous puissiez l’adapter à vos opérations. Seules les informations spécifiques au site doivent être saisies dans les champs de couleur rouge. Ceci couvre les installations de production Pharmaceutique, ce qui inclut une grande variété de techniques de fabrication. Le modèle/matrice DMS comprend les informations nécessaires pour la fabrication de comprimés, comprimés dragéifiés, capsules, pommades, crèmes, gels, suppositoires, suspensions, sirops, ampoules, inhalateurs, flacons et seringues.

The validation master plan (VMP) is a crucial documents as it describes the basic concept for your overall site validation program.

This 25-page VMP template for manufacturers of tablets, capsules, ointments, gels, creams and inhaled products, which has been updated in line with current industry standards, needs only a small amount of site-specific modification before it can be adopted for your operations.

The VMP addresses: process validation, facility qualification and validation, utility qualification and validation, equipment qualification and cleaning validation. Its objective is to outline the principles involved in the qualification and validation of your facility, define the areas and systems that are to be qualified and validated and provide a program for achieving and maintaining validated status.

The validation master plan (VMP) is a crucial document as it describes the basic concept for your overall site validation program.

This 26-page VMP template for manufacturers of drug substances/active pharmaceutical ingredients, which has been updated in line with current industry standards, needs only a small amount of site-specific modification before it can be adopted for your operations.

The VMP addresses: process validation, facility qualification and validation, utility qualification and validation, equipment qualification and cleaning validation. Its objective is to outline the principles involved in the qualification and validation of your facility, define the areas and systems that are to be qualified and validated and provide a program for achieving and maintaining validated status.

This ready-to-use quality audit questionnaire (audit by mail) has been created to assess potential contract laboratories, to test their quality standards and regulatory profile and reassure your company that the contract laboratory is able to operate in line with current good manufacturing/laboratory practices. The questionnaire also includes a covering letter, which only needs a small amount of site-specific modification before it can be used.

During on-site audit preparation work, this checklist can be used to draw up the audit agenda and help with the execution of a systematic on-site GMP audit. Please remember that as long as your company name is on the product to be tested, you are legally responsible for ensuring that the product tests carried out on your behalf meet all quality specifications and comply with all legal regulatory requirements imposed on testing.

Ensure compliance with CFR 21 Part 11 (EU GMP Annex 11) by establishing a clearly defined plan. You do not have to be a specialist in computerised systems to help your company meet the US FDA regulatory requirements of 21 CFR Part 11.

We have developed a master plan that enables you to initiate and coordinate all crucial Part 11 compliance activities. The first step in becoming Part 11-compliant is to set up a plan that details your Part 11 compliance strategy and the required milestones. Our Part 11 compliance plan is a ready-to-use master document that describes all the necessary steps such as creating compliance strategies, organisation, system determination, risk evaluation, system gap analysis and remediation.

The 13-page Part 11 compliance plan describes the compliance strategy and includes 4 attachments for site-specific information, e.g. list of computerised systems with risk categorisation, list of training needs and related SOPs to be adopted or updated. If you fall under the scope of the 21 CFR Part 11 (or EU GMP Annex 11) regulation, do not delay your compliance initiative for too long. The next inspection is sure to come and it would be better to have a plan in place.

Good distribution practice is one of the key elements of a successful business today, particularly when it comes to the transportation of pharmaceuticals that require cold shipment.

This Standard Operating Procedure (SOP) is applicable for facilities that receive/ship refrigerated products by truck or plane that must be stored at temperatures between 2 C to 8 C.

The 8-page Standard Operating Procedure (SOP) describes processes, responsibilities and accountabilities and needs only a small amount of site-specific modification before it can be used for your operations.

Efficient and safe cleaning is a crucial prerequisite for the manufacture of drug products or medical devices. The appropriate selection and control of cleaning agents (solvents, detergents and sanitizers) is an essential part of the entire cleaning process.

This Standard Operating Procedure (SOP) provides clear and structured guidance on how to evaluate and classify cleaning agents to ensure there is no interaction with drug products and manufacturing equipment. This Standard Operating Procedure (SOP) contains a 10-page process description with 3 attachments where you can list your cleaning agents. It is ready to use and only needs a small amount site-specific modification before it can be implemented in your operations.

This ready-to-use quality audit questionnaire (audit by mail) has been created to assess potential contract manufacturers and judge their ability to meet current GMP. This questionnaire also includes a covering letter, which needs only a small amount of modification before it can be used.

During any on-site audit preparation, this checklist could be used to draw up the audit agenda and help with a systematic on-site GMP audit. Please remember that as long as your company name is on the product to be manufactured, you are legally responsible for ensuring that the operations carried out on your behalf meet all quality specifications and comply with all legal regulatory requirements imposed on manufacturing and testing.

Have you thought about qualifying your cold chain transportation? Professional cold chain management practices are vital for ensuring product quality and patient safety.

We have compiled a 10-page qualification master plan that is available for all customers operating in a GMP and Good Distribution Practices (GDP) environment.

The ready-to-use qualification master plan for refrigerated shipment helps you to set up your qualification procedures. The master plan includes a 6-page protocol template and a 6-page report template, both of which need only a small amount of site-specific modification before you start your cold shipment transportation qualification.

If you want to outsource your medical devices test activities you must make sure that the data and reports you receive are accurate and meet the Medical Devices regulatory requirements for testing EN 17025 and Good Laboratory Practice (GLP) as well as ISO 13485. A Testing Agreement is a key step to comply on the one hand the regulatory requirements and on the other hand protect your company’s interest. The Testing Laboratory shall maintain an integrated quality management system which satisfies the international standards for quality management and quality systems for medical devices, including the international requirements of vigilance and traceability (EN ISO 13485 or equivalent).
In this connection, preference shall be given to the application of accredited testing methods or tests laid down by statute. Test shall be based on and conducted following US guidelines and EC directives, EN, ISO and IEC standards, Statutory provisions, National technical standards, Safety engineering, health and environmental protection rules and/or In-house testing programs and methods. Where statutory requirements exist, they shall be binding.
This 12 pages contract template with one attachment specifies agreements and controls needed to avoid misunderstandings that could result in a test result or work of unsatisfactory quality.

On this page you can purchase GMP Checklists. For more information on what GMP Checklists are click here.

On this page you can download free GMP documents. All we ask you to do is provide us with your email. You will be able to download your free GMP and SOP documents immediately after clicking the Submit bottom. If you need help feel free to contact us. Make sure to bookmark this page as we plan to offer more free document templates in the future.

On this page you can purchase Validation Master Plans. For more information on what Validation Master Plans also called VAMPs are click here.

On this page you can purchase Quality Contracts and Agreements. For more information on Quality Contracts are click here.

On this page you can purchase SOP documents. For more information on what SOPs also called Standard Operating Procedures are click here.