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 a Show all details
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, w Show all details
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 Show all details
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 me Show all details
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 Show all details
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 pr Show all details
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 Ope Show all details
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 com Show all details
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 practic Show all details
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. < Show all details
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 t Show all details
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 calibrat Show all details
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 docum Show all details
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, extern Show all details
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 th Show all details
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 au Show all details
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 governi Show all details
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 Show all details
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 pe Show all details
“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 produc Show all details
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 Show all details
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 carri Show all details
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 w Show all details
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.
Thi Show all details
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 Show all details
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 Show all details
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 th Show all details
Standard Operating Procedures (SOPs) must be written, approved and followed for any operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, medicinal product or medical devices to ensure consistent application.
Standard Operating Procedure (SOP)
An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature (e.g., equipment operation maintenance and cleaning, validation, cleaning of premises, environmental control, sampling and inspection, specific departmental activities, distribution activities). Certain SOPs may be used to supplement product-specific master and batch production documentation or distribution records.
Standard Operating Procedure (SOP) Management
A formal program at a site to ensure development, maintenance and archiving of SOPs for compliance to GMPs.
The Site Management Team must ensure that there are systems for creating, approving, maintaining and archiving Standard Operating Procedures for those
activities that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient or medicinal product.
Site Management must ensure that there is a system in place for training personnel on the Standard Operating Procedures applicable to their area of responsibilities.
The Site Quality Manager must approve all systems for creating, approving, and maintaining Standard Operating Procedures.
The site Quality Manager is responsible for approving or rejecting all site procedures that may potentially impact on the identity, strength, quality and purity or distribution of active pharmaceutical ingredient or medicinal product.
Forms and flow charts are recommended to improve understanding and facilitate use of
Standard Operating Procedures. When forms, flow charts and any other attachments
are used, they must be either:
Standard Operating Procedures must be written in a language that is understood by the user.
Standard Operating Procedures relevant to the activity must be available at the workplaces, as well as the current version of the forms, flow charts or other attachments to be used.
Measures must be taken to ensure that the copies, which are to be distributed, are identical to the original Standard Operating Procedure and distribution control must be maintained for “approved copies” or “paper copies”.
A system must be in place to ensure that superseded SOPs are removed and destroyed except for the approved signed originals that are archived according to document retention requirements.
Standard Operating Procedures must be written in sufficient detail so that the govern process is reliably repeated using only the procedure and attachments.
Personnel writing or reviewing procedures must have the expertise in the area, function or activity covered in the procedure and training in applicable Good Manufacturing Practice or related regulations.
Procedures must be clearly written, understandable by persons who are to follow them, and complete.
Procedures must be reviewed, and if necessary revised, at least every three two to ensure that the procedure is still valid.
If a revision is not needed the procedure must clearly show that it has been reviewed and its validity extended for another period.
A minimum set of Standard Operating Procedure should be available in GMP manufacturing areas for the following systems:
Deviation and change control
Training and organization
The release of raw materials and finished goods
Out of specification results
Material management and goods receipt
In process control IPC testing
The creation of SOPs
Corrective and preventive actions
Format and content of batch records
Qualification and validation
Setting up product specifications
Internal audit or the self inspection program
Lot numbering process