Good Manufacturing Practices (GMP) certification from SGS ensures the integrity of your food manufacturing process as well as your compliance with food safety regulations. A GMP is an important enhancement to your food safety management system, which increases your customers’ confidence in your commitment to trading and producing safe, high-quality food. Compliance with GMP requirements entails minimum common sense sanitary and processing requirements applicable to all food processing establishments. Compliance with GMP requirements entails minimum common sense sanitary and processing requirements applicable to all food processing establishments.
- Name of the applicant with address, telephone, fax, e-mail etc.
- Copy of Manufacturing License.
- List of approved products.
- Site Master file
- Data on Finished Formulation: -
- Master manufacturing formula, manufacturing process.
- Finished product specification and Method of Analysis.
- Stability study evaluation (Accelerated and Real Time) for 3 batches including details batch size, Batch No., Date of manufacturing, Date of Expiry, stability study condition (Accelerated/ Real time),
- Process validation report for 3 batches.
- Validation report of analytical method.
- List of technical staff, their qualification, and experience and approval status.
- List of equipment and instrument.
- List of SOPs and STPs.
- Manufacturing Plant layout.
- Schematic diagram of water system specifying circulation loop and MOC.
- Product summary sheet (as per Format B).
- Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
- Undertaking regarding compliance to the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under, etc.