Our quality professionals bring direct experience in pharmaceutical, biotechnology, and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of your product

Our GMP auditing services includes 

  • Vendor/ Supplier audits
  • Quality system and Corporate SOP GAP analysis
  • Mock preapproval inspections
  • Formal risk assessments and risk mittigation strategies

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

 

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