AUDITING SERVICES

Based upon the exceptional experience, knowledge and understanding handled audits of API, Finished dosage forms, Packaging materials, Excipients with the same level of professionalism as well as detailed-regardless if the audit requires accredited or non-accredited report. This serves to ensure Quality, Efficacy and Safety of medicinal products. Following table summarize the auditing capability of FWQRC

Type Standards/Guidelines Products
Good Manufacturing Practices (GMP) WHO GMP,
USFDA 21 CFR part 210, 211
EUGMP,
Schedule M ,
ASEAN GMP,
ICH Q7
Active Pharmaceutical Ingredients (API)
Excipients
Finished dosage forms (Solid)
Finished dosage forms (Liquid))
Finished dosage forms (Sterile)
Packaging materials
  USFDA 21 CFR part 820 Medical Devices
  USFDA 21 CFR part 117 Food products
  USFDA 21 CFR part 710,720 Cosmetic products
Quality Management Systems(QMS) ISO 9001:2015 Food, Drugs, Cosmetics & Medical Devices
Environmental Management Systems ISO 14001:2015 Food, Drugs, Cosmetics & Medical Devices Industries
Occupational Health & Safety Management ISO 45001:2018 Food, Drugs, Cosmetics & Medical Devices Industries