What Is GMP?
Good Manufacturing Practices
GMP is Good Manufacturing Practices GMP guidelines help to strengthen the manufacturing process to ensure products are consistently produced and controlled by the quality and safety standards for their intended use and comply the regulatory requirements by health authorities. By implementing GMP at any of food, pharmaceutical and food supply chain such as raw material and packaging suppliers can minimize the risks involved in production process. Currently it is noticed that GMP compliance requirements are rising in other than food and such as pharmaceutical industry and Textile manufacturing units.
GMP covers all aspects of the production process from initial stage material, facility and equipment to the training of personal hygiene of staff. Comprehensively written procedures are essential for each process that could affect the quality of the product. Detailed and effective documented system must be devised to provide documented evidence that correct procedures are consistently followed at each step in the manufacturing process – every time a product made.
It is a voluntary standard therefore it automatically fulfils the expectations of the customers and stakeholders regarding product quality and basic food safety practices.
Certification bodies conducts GMP audits on their own guidelines or checklist and sometimes on auditee’s requirement they refers the guidelines of regulator and country’s standard development authority such as PSQCA, Australian GMP guidelines, Canadian GMP guidelines, European GMP guidelines & US FDA GMP guidelines.
Benefits of GMP Certification
- Increased customer confidence
- Control & eliminate the risks that affects final product
- Ensure sustainable quality system to reduce the errors
- Ensure safe product use for humans
- Fulfill the regulatory requirements
- Prevent mislabeling & adulteration
- Enhance your brand image
- Helpful in attracting new customers
- Helpful to retain the confidence of existing customers
GMP Certification Process
After finalization of agreement with client, experts of Quality Systems visit at client’s premises and conduct the complete gap analysis of existing system against the GMP and discuss the gap report to the management, Identified gaps could be in documents, implementation, employee’s awareness, statutory and regulatory compliances.
We commence work according to the agreed timelines as per final gap report and proceed for the audit once all the documentation, implementation, and other requirements are done. Our technical team provides complete assistance, support and cooperation throughout the process to make certification audit successful in first attempt.
GMP certificate is not awarded once-and-for-all but must be renewed before expiry of the certificate. After applying for the audit to the certification body, they conduct the initial audit. After the successful conduction of audit, certification body issues the certificate of validity of one year till next yearly surveillance audit thus in three years of certification cycle, certification body conducts two surveillance audits with one year of intervals. Basically , audit will be conducted every year in the period of three years. After completion of three years of audit cycle re-audit will be conducted to continue the process of certification.
Cost of GMP Certification
Charges of GMP certification can not flat or same for every organization, please contact us in this regard.
Why Quality Systems
Quality Systems is working with the team of qualified and experienced consultants and trainers having vast industrial experience, most of our consultants are also lead auditors who are aware of the expectations of auditors from your management system during the audit. Quality systems is assisting across the world to implement and achieve the GMP certification. Our consultation methodology is highly professional, time bound and effective and we always add value to the business process of the client’s organization.
Our GMP complete package is comprised on following segments such as training, implementation, consultation, gap analysis, documentation, internal audits, pre assessment, certification audit through world’s most recognized accredited certification body and post certification enhancement / maintenance services to enable your organization to get the best outcome of GMP. Our services are globally accepted, authoritative and benchmarked in the field of GMP Good Manufacturing Practices.