Standard Operation Procedures
HPLC Calibration
New SOP
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
Operation, calibration and maintenance of electronic analytical single pan balances
NEW
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
Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench
NEW
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
Hosting Regulatory Inspections
NEW
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
Preventive maintenance (PM) procedure
NEW
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
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Annual product review
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
Supplier certification program
Updated Version
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
Change control system
Updated Version
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
Calibration of dissolution test apparatus (USP apparatus 1 and 2
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
Deviations (failure investigations, non-conformance)
Updated Version
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
Creating, reviewing, approving and issuing an SOP
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
Calibration program
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
GMP document management
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 do
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Corrective and preventive action (CAPA)
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, ex Show all details
NDA field alert
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
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Supplier audit program
Updated Version
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 supplie Show all details
Product Recall
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 gov Show all details
Self-inspection program
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 Show all details
Training
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 temporar Show all details
Batch reprocessing and reworking for API (active pharmaceutical ingredients)
Updated Version
“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 pr Show all details
Investigation of complaints
Updated Version
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 Show all details
Handling of OOS results
Updated Version
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 c Show all details
Returned drug products
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 t Show all details
Classification evaluation approval of cleaning agents
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.
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SOP for refrigerated shipment
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 rece
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Pest control program
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 incl Show all details
Handling of chemicals, reagents and solutions in laboratories
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 an Show all details
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The term or abbreviation SOP - Standard Operation Procedures is widely used but specifically in the manufacture of drug products, APIs (Active Pharmaceutical Ingredients), biologics, devices and the food and cosmetic industry.
A SOP (Standard Operating Procedure) contains instructions having the force of a directive, covering those features of Operatings that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating/Operating Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational and Operatingal results. They assure that processes and manufacture will be done in a similar way and lead always to the expected quality of product. SOPs must be followed by operators performing the manufacture and the testing of drugs.
Each efficient quality management system is based on its standard Operating procedures (SOPs). In clinical research, standard operating / Operating procedures (SOPs) are defined by the International Conference on Harmonization (ICH) as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs are necessary for a clinical research organization whether it concerns a pharmaceutical company, a sponsor, a contract research organization, an investigator site, an Ethics Committee or any other party involved in clinical research to achieve maximum safety and efficiency of the performed clinical research Operatings.
It is therefore a must that all people and sites involved in clinical studies (both at the sponsor and at the investigative sites) have appropriate SOPs in place in order to conduct clinical research and to ensure compliance with the current regulations. The ICH GCP (good clinical practice) Step 5 Guideline (Section 3.2.2) also suggests that an Institutional Review Board (IRB) have its own SOPs or written standard procedures. This it self proves that presence of SOPs are an integral part of the clinical trial at all levels.
The presence of these quality documents is essential when regulatory inspections (FDA, EMEA) take place since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GMP non-compliance is high at organizations with a poor availability of specific SOPs and also if at all they are available the staff or the people for whom they were written are not either following them.
It therefore becomes very important for the personnel to be trained on these SOPs so that they are actually aware of why and how SOPs can play important role in fulfilling the specific regulatory requirements from WHO, FDA, EMEA or other national health authorities.
Health authorities world wide like the FDA or EMEA expect pharmaceutical, cosmetic and food producers to describe their manufacturing processes in written SOPs.
A minimum set of Standard Operating Procedure should be available in GMP manufacturing areas for the following systems:
quality management
deviation and change control
training and organization
complaints
Recalls
preventive maintenance
the release of raw materials and finished goods
out of specification results
environmental monitoring
material management and goods receipt
pest control
QC testing
in process control IPC testing
document management
the creation of SOPs
corrective and preventive actions
format and content of batch records
qualification and validation
setting up product specifications
supplier qualification
internal audit or the self inspection program
lot numbering process
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