What is GMP Certification?
Good producing observe (GMP) could be a system for guaranteeing that product area unit systematically made and controlled in line with quality standards. it's designed to reduce the risks concerned in any pharmaceutical production that can't be eliminated through testing the ultimate product. the most risks are: sudden contamination of product, inflicting injury to health or maybe death; incorrect labels on containers, that may mean that patients receive the incorrect medicine; meager or an excessive amount of active ingredient, leading to ineffective treatment or adverse effects.
Benefits of GMP Certification?
GMP (Good Manufacturing Practices) certification in India is a critical benchmark for pharmaceutical, food, and cosmetic companies. This certification signifies adherence to stringent quality standards in manufacturing processes. The benefits of GMP certification are substantial. Firstly, it ensures product safety and quality, safeguarding consumers from substandard or harmful products. Secondly, it enhances the reputation and credibility of the certified company, instilling trust among customers, regulators, and partners. GMP certification is often a requirement for market access, both domestically and internationally, making it a crucial factor in expanding a business's reach. It also reduces the risk of regulatory non-compliance, which can lead to costly recalls and legal issues. Moreover, GMP practices improve operational efficiency, minimize waste, and reduce production errors, resulting in cost savings. Overall, GMP certification not only assures product quality and safety but also fosters competitiveness, market access, and long-term business sustainability in India's highly regulated industries.
Document Required
- Applicant name with confirmed address
- Copy of Manufacturing Licence
- List of approved products
- Site Master file
- Master manufacturing formula
- Manufacturing process
- Finished product specification and Method of Analysis
- Stability study evaluation for three batches (Batch size, Batch No, Date of manufacturing, Date of Expiry, stability study condition)
- Process validation report for three batches
- Validation report of the analytical method
- List of technical staff
- Technical staff qualification, experience, and approval status
- List of equipment and instrument
- List of SOPs and STPs
- Manufacturing Plant layout
- Schematic diagram of the water system
- Product summary sheet
- Proof of safety and effectiveness
- Mobile No & Email ID