Home / GMP Certification in India
Updated on : 22-Jan-2020 05:40 AM IST | 4 min read
What Is Good Manufacturing Practices (GMP) Certificate?
GMP stands for Good manufacturing practices. GMP certificate is the certificate given to the firms or businesses in order to ensure that products are properly manufactured and controlled as per quality standards set by GMP. GMP certificate is issued to safeguard the health of consumers and patients as well as for producing good quality products.
Every country (either developed or developing) has its own GMP guidelines. More or less GMP guidelines for every country are similar but there are different enforcement agencies that are having the responsibility to ensure whether all the guidelines are properly implemented.
In case you are exporting your products globally, it is necessary for you to be compliant with GMP guidelines in order to fulfill the requirements of these agencies. GMP certificate provided by Finacbooks has recognition in different countries worldwide. Contact us today to fulfill all your GMP needs.
GMP guidelines tells us different ways to manufacture certain products like food, Ayurveda products, pharmaceuticals, cosmetics, medical devices and packaging by maintaining the highest standards of quality. The conditions mentioned in GMP are related to safety of the product, record-keeping, cleanliness, hygiene, sanitation, documentation, equipment verification, clean room concept and concerned trainings, complaint handling etc.
Every manufacturer should implement controls during manufacturing process to produce high quality products and every individual should decide himself or herself that what is the best way to implement the necessary controls?
GMP guidelines ensure good manufacturing process which enable many companies to minimize or eliminate contamination, mix up and errors which in turn leads to protection of consumers from purchasing an ineffective or a dangerous product. In case the firm fails to comply with GMP guidelines, it may result in serious consequences such as recall, fines, seizure and jail term.
What Is Included In Our Package?
Whether GMP is necessary in the presence of quality control laboratory?
Yes, product should be made up of good quality during the manufacturing process. We need to have good & controlled manufacturing process in order to produce a quality product. Laboratory is the place where the product is tested but once you are done with producing the product, you cannot change the quality of that particular product in the laboratory. In the absence of GMP, it is not possible to ensure that every unit of medicine is of the same quality at the time of testing it in the laboratory.
GMP costing - Whether manufacturers afford to implement GMP?
Making of poor quality products does not save your money but it will create problems for you in the long run. It is very expensive to find an error first and then correct that mistake. GMP is created to eliminate the errors happen during the manufacturing process of the product or to ensure that no mistake will never ever occur again in future. Proper implementation of GMP guidelines will improve the health of the consumer as well as patients. It will also benefit the pharmaceutical industry and health professionals too.
Manufacturing and distribution of poor quality products will leads to loss of reliability for public & private health care as well as for the manufacturers.
Who works to strengthen GMP?
World health organization works to strengthen GMP. All WHO GMP guidelines are available online. In case you want more information, kindly contact WHO representative in your country or WHO regional office or headquarters of WHO in Geneva.
Benefits of GMP Certification
The benefits of GMP certificate are as follows –
- It provide guidelines on how to manufacture safe & quality products
- It increases the level of customer satisfaction by delivering safety & quality products to the consumers.
- It improves the brand value of the company in the market.
- It develops motivation and raises the spirit of team work among the employees of the organization.
Process of GMP Certification
The process of GMP certification is as follows –
Firstly fill the application form by putting some basic details of the company. The certification body accepts the application and record all the information on the GMP database.
In the second step, GMP certification team will review the application to ensure that all the compliance requirements are fulfilled.
After reviewing the documents, GMP team provide the price quotation to the client and do the gap analysis (Done to see the gap between the planned & achieved things of the company) in order to cover all the sections and clauses of the quality standards.
In the fourth step, documents of the organization are checked by the compliance team to ensure that whether the documents are fulfilling the compliance requirement or not.
In the fifth step, GMP team starts stage-1 audit in which audit team analyze and evaluate the documentation procedure of your organization as well as policies against the compliance requirement.
After completing stage-1 audit, stage-2 audit is started by the auditor to verify that the client is implementing as per documentation. In case, the auditor of the team identifies the non-conformities, auditor gives a chance to the organization to correct those non-conformities.
After checking the organization in Audit-2, auditor gives the approval to the certification authority that everything is checked and correct. The certification body issues a compliance certificate to the client which is valid for 3 years.
In step-8, Surveillance audit has been conducted by the compliance authority to check that whether the organization is still complying with GMP guidelines or not. It is performed by the auditors in every six months or one year after issuing of the certificate.
Finally, Recertification process is started by the client after the end of 3 years tenure.