Dr. Claren Woo (Section Manager, Life Sciences Service) presented “Environmental Monitoring of Facilities” and “Quality Control for Analytical Test”. After that Ms. Cherry Lau (Sr. Technical Executive) gave the last two sessions entitled “GMP for Warehouses and Distribution Centres” and “Microbiology Laboratory”.
Dr. Woo introduced different types of cleanroom classes as follows:
International: ISO 14644 & WHO
National: EU GGMP, EC PIC/S, TGA, FDA & ISPE
The following method characteristics were considered for test method validation.
- Specificity (Selectivity)
- Accuracy and Precision
- Detection Limit and Quantitation Limit
- Robustness and Stress Test
Specificity and Robustness were selected to further describe below.
Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present. Typically these might include impurities, degradants, matrix, etc.
The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
The follows are some international guidelines for stability studies:
ICH: Q1A(R2) “Stability Testing of New Drug Substance and Products”
ASEAN: Guideline “Stability Studies of Drug Products”
US FDA: Guidance for Industry “Stability Testing of Drug Substances and Drug Products: June 1998”
WHO: TRS 863, Annex 5: “Guidelines for Stability Testing of Pharmaceutical Products Containing Well Established Drug Substances in Conventional Dosage Forms”
EMEA: Note for Guidance on Stability Testing of Existing Active Substance and Related Finished Products (Draft), Feb 2002.
In the last two sessions, Cherry introduced GDP for pharmaceutical products in which cold chain management was included.
It concerns if the required temperature and relative humidity is maintained inside the delivery case of pharmaceutical products. (e.g. using cold chain for thermolabile products)
GDP concerns about:
i) microbial contamination source,
ii) temperature & humidity requirements, and
iii) counterfeit products detection and handling.
Lastly, she introduced different functions in microbiology laboratory.
For microbial identification, morphology is the fundamental information.
Api system is a tool commonly used for microbial identification.
Water testing is also important. Some test methods were discussed below:
- Total Viable Count (TVC) using Membrane Filtration / Spread Plate
- Endotoxin using LAL test (Limulus amebocyte lysate) / KQCL (Kinetic Chromogenic LAL Assay)
After the 3-day course, I learnt a lot of basic knowledge of GMP for pharmaceutical manufacturing. The course was found very intensive and informative.