Day 2 (15 Dec 2009)
Ms. Cherry Lau (Sr. Technical Executive) presented another four sessions on day 2, including “Materials Management; Documentation & Record Keeping”, “Production and Quality Control” and “GMP for Active Pharmaceutical Ingredients (APIs)”
The usage of Water for pharmaceutical was also introduced. Different types of water used in pharmaceutical processes were showed as follows:
i) Purified Water
ii) Water for Injections (WFI)
iii) Softened Water (removal of calcium and magnesium)
iv) Water for Final Rinse
v) Pure, or Clean Steam
vi) Water for Cooling Autoclaves
There were five types of contaminant groups in water.
i) Inorganic compounds (e.g. chloramines, magnesium carbonate, etc.)
ii) Organic compounds (e.g. detergent residues, solvents, etc.)
iii) Solids (e.g. clay, soils)
iv) Gases (e.g. N2, CO2, O2, etc.)
v) Micro-organisms which can grow in nutrient-depleted conditions
The most troublesome contaminant of water is Biofilm which is formed by micro-organisms. Biofilm formation comes from the follow steps:
i) Free swimming aquatic bacteria use polymucosaccharides to colonise surfaces.
ii) Complex communities evolve which shed micro-colonies and bacteria.
One of water testing methods is membrane filtration which could isolate microbial contaminant for identification.
After that the specific requirements for following types of materials were reviewed:
- Starting materials
- Packaging materials
- Intermediate and bulk products
- Finished products
- Rejected and recovered materials
- Recalled products
- Returned goods
- Reagents and culture media
- Reference standards
- Waste materials
- Miscellaneous materials
Documentation is an essential part of QA and related to all aspects of GMP which ensures that specifications for all materials and methods of manufacture and control are available; assures all personnel know what to do and when to do it; and ensure that Authorized Persons will has all information necessary for release; as well as, all documents available for audit trail.
There were different types of documentation below:
- Labels, specifications and master formulae
- Batch processing and batch packaging records
- Standard operating procedures
- Stock control and distribution records
- Water quality manual, etc.
Then trainer briefed the FDA inspection and showed the most common GMP deficiencies by systems as follows:
- Quality (46%)
- Laboratory (19%)
- Facilities of equipment (17%)
- Production (11%)
- Material (6%)
- Packaging & labeling (1%)
At the end, the GMP guidelines for manufacturing of Active Pharmaceutical Ingredients (APIs) were discussed. It covered “General considerations”, “Personnel”, “Premises”, “Equipment”, “Sanitation”, “Documentation”, “Retention of records and sample” and “Production”.
GMP of APIs is governed by Technical Requirements of International Conference on Harmonization (ICH) for registration of Pharmaceuticals for Human Use (ICH Q7). It was established in 1999 and aims to increase international harmonization of technical requirements to ensure that safe, effective, high quality medicines are developed and registered in the most efficient and cost-effective manner.