What is GMP?
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
GMP is also sometimes referred to as “cGMP”. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Poor quality medicines can damage health
A poor quality medicine may contain toxic substances that have been unintentionally added.
A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
GMP helps boost pharmaceutical export opportunities
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries’ export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
Is GMP necessary if there is a quality control laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Can manufacturers afford to implement GMP?
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
How to gain registration?
The process of registration follows three simple steps:
· Application for registration is made by completing the questionnaire
· Assessment to GMP is undertaken by QI. This consists of two mandatory visits which form the Initial Certification Audit
· Registration is granted by QI and maintained by the client. Maintenance is confirmed through a programme of annual surveillance visits and a three yearly re-certification audit.
Initial Certification Audit
Stage 1 – the purpose of this visit is to confirm the readiness of the organisation for full assessment.
The assessor will:
· confirm that the GMP system conforms to the requirements of the standard including the identification of impacts and aspects
· confirm its implementation status
· confirm the scope of certification
· check legislative compliance
· produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required
· produce an assessment plan and confirm a date for the Stage 2 assessment visit.
Stage 2 – the purpose of this visit is to confirm that the quality production system fully conforms to the requirements of GMP in practice.
The assessor will:
· undertake sample audits of the processes and activities defined in the scope of assessment
· document how the system complies with the standard report any non-compliances or potential for noncompliance
· produce a surveillance plan and confirm a date for the first surveillance visit
If the assessor identifies any major non-conformance, the organisation cannot be certified until corrective action is taken and verified.
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