We provide the best Services for your GMP Certification.
GMP stands for Good Manufacturing Practice, and the term is used globally to manage the control and management of pharmaceutical manufacturing, testing, and overall quality. It defines certain guidelines that discuss the quality assurance approach. GMP certification ensures that products are produced in accordance with quality standards.
Benefits of having GMP Certification
Certifying GMP or cGMP can provide a facility/company/organization with the following benefits, among others: Establishes that the organization is adhering to WHO or FDA guidelines, as well as local nationalized standards and guidelines.
Maintains hygiene and cleanliness standards throughout the manufacturing and logistics chains.
Documents (e.g., manuals, procedures, standard operating procedures, operational controls, risk assessments, regulatory compliances, etc.) and records for evidence are examples of good documentation practices.
Design and operation of Medical Devices, IVD products/items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items, including management of processes and products.
Establishes the Organization’s system for dealing with Non-Conformities and Complaints, including proper reporting to Regulatory bodies as needed.
Reduction Cost reduction and best possible resource utilization
Proof of Safe and High-Quality Products and Items
All international, national, and local regulations must be followed.
Increases customer assurance, rapport, and trust.
International Market Entry
Within the organization, there is a professional culture.
Complaints, fines, product returns, re-processing, rejections, non-conformities, and claims are all reduced.
GMP Certification Prerequisites
Manufacturing facility design, equipment and machinery design, procedures and operating principles, and environmental conditions must all be controlled.
Manufacturing practices and processes, such as health and safety, maintenance, and so on, must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications.
Operators should be aware, trained, and competent to carry out production, QA/QC, Logistics, Factory Management, and product control throughout the manufacturing process.
Records should be kept for manufacturing, quality control, and logistics, demonstrating that all steps required by the defined procedures and instructions have been taken.
According to regulatory requirements, records should be kept for 5 to 10 years.