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 |