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The ECA Academy is receiving a lot of
questions on SOPs (Standard Operating Procedures) needed in a GMP
environment. The most interesting is the one on which SOPs are required by
law. Here is an Overview:
U.S. Food and Drug
Administration (FDA):
A three year old Notice focusing
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:
- Section
211.22(d)-Responsibilities and procedures of the quality control unit;
- Section 211.56(b)-Sanitation
procedures
- Section 211.56(c)-Use of
suitable rodenticides, insecticides, fungicides, sanitizing agents;
- Section 211.67(b)-Cleaning and
maintenance of equipment;
- Section 211.68(a)-Proper
performance of automatic, mechanical, and electronic equipment;
- Section 211.80(a)-Receipt,
identification, storage, handling, sampling, testing, and approval or
rejection of components and drug product containers or closures;
- Section 211.94(d)-Standards or
specifications, methods of testing, and methods of cleaning,
sterilizing, and processing to remove pyrogenic properties for drug
product containers and closures;
- Section 211.100(a)-Production
and process control;
- Section 211.110(a)-Sampling and
testing of in-process materials and drug products;
- Section 211.113(a)-Prevention of
objectionable microorganisms in drug products not required to be
sterile;
- Section 211.113(b)-Prevention of
microbiological contamination of drug products purporting to be sterile,
including validation of any sterilization process;
- Section 211.115(a)-System for
reprocessing batches that do not conform to standards or specifications,
to insure that reprocessed batches conform with all established
standards, specifications, and characteristics;
- Section 211.122(a)-Receipt,
identification, storage, handling, sampling, examination and/or testing
of labeling and packaging materials;
- Section 211.125(f)-Control
procedures for the issuance of labeling;
- Section 211.130-Packaging and
label operations, prevention of mixup and cross contamination,
identification and handling of filed drug product containers that are
set aside and held in unlabeled condition, and identification of the
drug product with a lot or control number that permits determination of
the history of the manufacture and control of the batch;
- Section 211.142-Warehousing;
- Section 211.150-Distribution of
drug products;
- Section 211.160-Laboratory
controls;
- Section 211.165(c)-Testing and
release for distribution;
- Section 211.166(a)-Stability
testing;
- Section 211.167-Special testing
requirements;
- Section 211.180(f)-Notification
of responsible officials of investigations, recalls, reports of
inspectional observations, and any regulatory actions relating to good
manufacturing practice;
- Section 211.198(a)-Written and
oral complaint procedures, including quality involving specifications
failures, and serious and unexpected adverse drug experiences;
- Section 211.204-Holding,
testing, and reprocessing of returned drug products; and
- Section 211.208-Drug product
salvaging.
European Union:
SOPs required by EU-GMP are mainly
defined 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:
- Validation and qualification of
processes, equipment and systems;
- Equipment assembly and
calibration;
- Technology transfer;
- Maintenance, cleaning and
sanitation;
- Personnel matters including
signature lists, training in GMP and technical matters, clothing and
hygiene and verification of the effectiveness of training.
- Environmental monitoring;
- Pest control;
- Complaints;
- Recalls;
- Returns;
- Change control;
- Investigations into deviations
and non-conformances;
- Internal quality/GMP compliance
audits;
- Summaries of records where
appropriate (e.g. product quality review);
- Supplier audits."
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"):
- Raw Materials
- Biological Starting Materials
- Facility
- Equipment (Production and QC)
- Production
- Labelling and Packaging
- Quality Control
- Quality Assurance
The examples from FDA, EU and
WHO provided above are not a finite list. Some topics might be split in
a number of SOPs for the sake of practicality. Some other company or quality
system specific processes might be defined in SOPs as well.
Link source:
http://www.gmp-compliance.org/enews_04431_Which-SOPs-are-required-by-GMP.html
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