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SOP required to ensure GMP compliance - 26 Aug 2014

Which SOPs are mandatory in order to comply with cGMP requirements?  Although there is no one size fits all approach to SOPs in pharmaceutical operations, there are indications as to which SOPs are considered mandatory and may be requested for during a GMP inspection.  Generally, the requirements are broadly discussed below:

U.S. Food and Drug Administration (FDA):The US FDA in its Federal Register (Vol. 76, No. 188 / Wednesday, September 28, 2011)  which provided further insights on specific recordkeeping requirements in the Federal Register also gives a very good summary of SOPs required by 21 CFR Part 211:

"Written procedures (standard operating procedures - SOPs), are required for many Part 211 records. The current SOP requirements were initially provided in a final rule published in the Federal Register of September 29, 1978 (43 FR 45014), and are now an integral and familiar part of the drug manufacturing process."

The 25 SOPs provisions under Part 211 include:

European Union:SOPs required by EU-GMP are generally clarified in the EU Guidelines to Good Manufacturing Practice of Eudralex Vol. 4 (EU-GMP Guide).  There is no comprehensive list provided but Chapter 4 of Part 1 (Documentation) of the Guide gives some examples:

"There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:

Chapter 4.30 requires that operating procedures "should be available for major items of manufacturing and test equipment."

World Health Organisation (WHO)A very comprehensive list can be found in the WHO guide to good manufacturing practice (GMP) requirements Part 1: Standard operating procedures and master formulae. Although written as part of the Global Programme for Vaccines and Immunization, Vaccine Supply and Quality, this overview gives valuable guidance also for other pharmaceutical companies.

More than 75 SOPs are listed from the following areas in Appendix 1 ("List of Document Requirements"):

The examples from FDA, EU and WHO provided above do not provide an exhaustive list. It is worth noting that some topics might be split in a number of SOPs to enable ease of management. In addition, company peculiar or quality system specific processes might be defined in further SOPs as well.

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