Implementation of Good Manufacturing Practices (cGMP) and Good Laboratory Practices
● Expertise in GMP and GLP with reference to Sterile Process Operations.
● Good exposure on national and international regulatory requirements.
● Expertise in SOP Preparation, Internal audits, Inter-Laboratory programs and
● Good exposure in maintaining microbiological cultures (ATCC / NCTC).
● Strong in Microbiological assays for Antibiotics and Vitamins.
● Microbial Limit Test for Identification and Determination of Microbiological Contaminants
in Water, Food and Beverages and Pharmaceuticals.
● Pharmaceutical Tests - Sterility, BET.
● Challenge Tests, Preservative Efficiency Tests.
● Microbial Trend Analysis.
● Good exposure on regulatory guidelines from BP, IP, USFDA, USP and EP, 21 CFR, ISO
9001:2015, ISO 14001:2015, ISO 19011:2018, Quality 4.0 Technologies / Methodologies.