In this post, we will explain the different cGMP available, which one you should consider and how to use them. We will dissect how you can read these rules and make them meaningful in your daily work.
What are the cGMPs?
In pharmaceutical manufacturing, there are a series of practices we apply during the manufacturing of drugs that ensure the quality of the product. Those rules need to be put in the context of your product and process. Good Manufacturing Practices (GMP) are the principles and guidelines to be respected for the manufacture of medicinal products for human and veterinary use.
GMP stands for Good Manufacturing Practices. The “c” that precedes it stands for “current”.
This little c is VERY important. The rules are written to allow for innovation and the need to strike the balance between protecting the patient, guiding the manufacturing activities and allowing continuous improvement. To explain it simply, the way we complied with the rules 20 years ago is not the way we currently do so, but the intention to keep the patient safe is always the same. Knowledge, technical solutions, and hence practices have improved to make things safer, more effective and efficient. This ‘c’ is to remind us to get better.
Where to find GMP?
The best-known cGMPs are without doubt those from:
- The United States, under the Food and Drug Administration (FDA ) under the Code of Federal Regulation (CFR) part 210 and part 211 and
- Europe, under the European Medical Agency (EMA) under the Eudralex Volume 4.
- If you are in the ASEAN region the PIC/s cGMP plays an important role (but we will develop this in another post) – for now just consider they are the same as the Eudralex Volume 4.
- And because we are in Singapore we will follow the Health Sciences Authority which states:
“…As a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), we adopt the PIC/S Guide to GMP for Medicinal Products (Part I) and its relevant annexes as our current GMP standards. Our GMP auditors will conduct audits on local manufacturers of therapeutic product and CPM for compliance with these GMP standards…”
Which cGMP to follow?
Before being placed on the market, medicinal products are subject to the marketing authorisation system, which guarantees that all medicinal products for human or veterinary use have been evaluated by a competent authority to ensure that they comply with quality, safety and effectiveness requirements.
The cGMP applicable to medicinal products is a legislative reference enforceable during inspections of pharmaceutical undertakings performed by the competent authorities. Manufacturing will need to comply with the cGMP in the country it manufactures the drugs and any market authorisation (the country where the drug can be sold). It is then easy to appreciate the importance of harmonising the cGMP rules. More on that in a future post, but looking at points 4,3, and 2 above you can see how this is achieved.
How to read the cGMP?
By now you should have clicked on the aforementioned links and read the content of the cGMP text. If not, don’t fret, we will extract an example for you.
Subpart C—Buildings and Facilities
(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.
(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, labelling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labelling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.
We have highlighted some key words:
- Prevent mixups
- Designed to prevent contamination
Those are the cGMP requirements.
The definition of Suitable, Adequate,…should be understood in the context of your product and process and the current technical solution available. Those solutions would be quite different for a Biologic, Oral Solid Dosage or API (also API cGMP are ICHQ7, but more to come in yet another post).
This is also why the different regulator publishes guidelines helping the industry to define adequacy. There are also many standards that could be used from associations such as ISPE, PDA,…
The guidance and rules serve only one purpose — protecting the patient from an adulterated product. Taking them in isolation will not give you the full picture of “how-to”, but can help you to understand why certain practices or designs are implemented in your workplace. Download them in PDF and enjoy using the search function with a keyword related to your task. Try things like: “Piping, Filter, Deviation,…” and familiarise yourself with those great quality enablers that are freely available on the Internet. Soon enough your curiosity will map all those rules into a net of knowledge empowering you to change for the better.
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Pierre is a Chemical Engineer and the CEO of No deviation. He likes to develop a team vision for quality accountability and innovation. He is hugely optimistic and sees the opportunity in every task he undertakes.