Good Manufacturing Practice or commonly known as GMP is used worldwide for managing the organizing and managing of manufacturing and testing procedure of pharmaceutical products. GMP certification ensures that pharmaceutical products are manufactured as per the prescribed quality standards. GMP deals with record-keeping, documentation, sanitation, cleanliness, complaint handling, process validation and equipment verification in India. Goods Manufacturing Practice (GMP) aims to reduce the risk factor in pharmaceutical products manufacturing. These products include risks such as inaccurate labels on containers, fewer ingredients in pharmaceutical products, ineffective treatment or causing an unpleasant effect.
Under GMP, various authorities are covering all the characteristics of production from raw materials, details regarding equipment and training for the staff and personal hygiene of employees. The World Health Organization has set specific rules and regulations for GMP. Several nations have defined their necessities for Goods Manufacturing Practice based on the guidelines of WHO. Others have set their conditions, for instance, in the European Union, in the Association of South-East Asian Nations and through the Pharmaceutical Inspection Convention (PIC).
GMP protects the final product from any faults that cannot be ignored for the quality product. Without the GMP certification, it is hard to ensure that each unit of medication is of similar quality as the units tested in the research of the medication.
GMP guidelines require dealing with the manufacturing, and helping organizations to reduce mistakes, contamination and misunderstandings. GMP Certification protects the customer from buying a product which is not up to the quality standards.
Advantages of GMP Certification in India
Following are the advantages of GMP Certificate in India:
Improve overall credibility and improve the public image.
Manages the issues and timely identify creation.
Prove the association's management abilities in term quality, wellbeing assurance.
Reduce risk in product quality and safety.
Increase the client's trust in the venture.
Better comprehend and conform to important rules, regulations and laws.
Guidelines for GMP Certification
Techniques and Directions are mentioned in clear and definite.
Records are kept manually during manufacturing, which indicates that the characterized guidelines and systems were taken and the nature and amount of the medication were accurate to form. Deviations are explored and recorded.
Administrators are prepared to conduct document procedures.
A system is available for reviewing any cluster from sale or supply.
Records of production and manufacturing enable the past of a batch to be followed held in an available and conceivable structure.
Investigation of all the complaints regarding promoted products and finding the causes for quality deficiency, and some measures are taken for the scarce items and to avoid repetitions.
The manufacturing process is unambiguously controlled and exemplified. Every basic process is approved to guarantee consistency with information.
The pharmaceutical office has to maintain its manufacturing unit clean and spotless.
Procedure to get GMP Certification
Fill in the application form:
The first step of the GMP Certification process is to fill the application form, which covers some vital data of the establishment. The affirmation body must acknowledge the registration application and requirements to record and keep all the data on the GMP database.
Review of application:
The application will be surveyed by a group to guarantee that all the necessity has been satisfied.
Review of Documents:
Check all the documents of the organization to guarantee that the documentation satisfied the compliance requirement or condition.
Granting of Certification:
After all the verification, the Certification Body will issue a certificate of compliance, which is substantial for a long time.
Surveillance Audit:
The main purpose of Surveillance Audit is to guarantee that the association meets the prerequisites of the administration framework. Observation should be conducted in every six months or one year from the date of the issued certificate.
Why is GMP Certification necessary?
Good Manufacturing Practice certification is designed to guarantee that mistakes don’t happen. The execution of GMP certificate in India is an interest in great quality medications; this will improve the health of a particular patient and the network. Making and distributing low-quality drugs prompts loss of validity for everybody (both private and public social insurance and the manufacturer). GMP is a decent business device, which will assist both the execution and consistency of the company.
Conclusion
Today, the requirement of GMP Certification for drugs turnover in the word are compulsory for both foreign and domestic producers. Various nations have defined their necessities for GMP based on WHO GMP. Others have fit their conditions, for instance, in the ASEAN (Association of South-East Asian Nations), in the European Union, and through the Pharmaceutical Inspection Convention.GMP Certificate in India deals with record-keeping, documentation, sanitation, cleanliness, equipment verification, complaint handling, and process validation.