GMP’s in foreign material control
Since foreign material control is a matter of grave importance to the American public, there are several Good Manufacturing Processes (GMP’s) that are in place for this industry. As defined by the FDA; GMP’s for foreign material control include facility, processing and employee practices aimed primarily at microbial control, but also foreign material control.The reason for which GMP’s have to be put in place in the foreign material control area is that they ensure food security.These are some of them:
GMP’s in foreign material control start with the people in the industry. No matter how much mechanization has taken place; it is the people who power the industry. It is also the easiest of GMP’s to control, and also the most impactful. Staff must ensure that they avoid unintended or deliberate actions that could cause contamination in food. They should be made to remove personal items like hairpins, clips, rings or any other such material that could potentially cause a contamination. Employee access to on-site contaminants such as equipment parts and tools should be restricted.
Next to people; the obvious GMP is facilities. Maintaining a clean and systematic facility serves two important functions: it prevents unwanted items from entering the facility; its manufacturing process and supply chain, and also sets the standard for employees working in the facility. It gives workers a view of how the organization functions. This ensures cleanliness in the food product and makes detection of any non-standard products, ingredients that go into them and other such items easier.
Facility and equipment maintenance
Tools and equipment parts should be stored in secured areas when they are not in use; every item should be accounted for, and a post inspection of the site should be carried out.
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The ICH Q 7 A–important sections
The ICH Q 7 A is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.
The Q 7 was arrived at by the International Conference of Harmonization (ICH), which is why it gets its name. Adapted in November 2000, it came into being after three of the world’s leading medical device markets, namely the EU, Japan and the US agreed to it.
Although a comprehensive guideline that covers almost all aspects of GMP for API in its 19 section; a few sections are more important than the rest. It makes sense to be aware of these sections and implement them for day-to-day use.
- Introduction and glossary: Most people only glance at this section and its sub-sections, but it contains very important details. For instance, it contains unique definitions, especially those on API starting materials and manufacturing. Unique definitions by experts are carried here. They help to properly apply the intent of Q 7.
- Buildings and facilities: Extremely important because it contains reference to minimum quality of potable water, closed systems and contact utilities.
- Process equipment and cleaning:This states that contact surfaces of all materials should not be able to alter the quality of the product or the material beyond stated or established requirements.
- Production and in–process controls: This section is vital because it states that deviations need to be documented under API GMP.
- Process Validation: Undoubtedly the most critical section of GMP, because this is what qualifies and validates a process. It also carries important issues such as qualification vs. validation.
- Rejection and reuse of materials: Q 7 is perhaps the only document that precisely defines these terms. But for this, there would be considerable confusion about what we would be doing under API GMP.
- Agents: Outcome of the Haitian situation in the mid-1990’s, where children died from glycerubecontamination; this requires maintenance and traceability of records and processes from manufacturer to user.