GMP Certification
What is GMP (Good Manufacturing Practice)?
GMP is termed as Good Manufacturing Practices which are required to conform to the guidelines recommended by certifying agencies that control the authorization and licensing of manufacture and sale of food and beverages, pharmaceutical products, medical devices, and cosmetics. GMP Certification guidelines provide minimum requirements that in an organization to meet their products produced as per standards with high quality, from batch to batch for their intended use.
GMP aims to ensure that no defective product should reach the end-user, thereby strengthening the process and product quality. GMP is typically monitored through the Quality Management System(QMS) practiced in the organization from set up to the final product. GMP ensures that the product has been checked for quality more than just at the end phase.
GMP along with GAP ( good agricultural practices ), GLP ( good laboratory practices ), and GCP ( good clinical practices ) are monitored by authorized agencies in the UK, US, Europe, India, and other countries.
According to their need and legislated, countries have their GMP that manufacturers follow the procedures and create their GMP guidelines that correspond to their legislation.
What are the basic principles of GMP?
There are few basic principles that all the guidelines will follow as below :
Facilities in the manufacturing area must maintain clean and hygienic space.
Manufacturing should be performed in controlled environmental conditions to prevent cross-contamination from adulterants and allergens that may render the product unsafe for the intended use.
Manufacturing processes in each step need to be defined and controlled. The critical processes need to be defined and validate regularly to contain compliance.
Changes in the process need to evaluated and changes in the quality of the product need to be validated to ensure the customer requirement.
Process parameters, instructions, and procedures need to be visible to the operator to perform the specified task.
Regular training to operators regarding the process change and evaluating the operator.
Documenting the process either manual or electrical for the ongoing process and note any deviations.
Deviation in the process needs to be investigated and documented.
Traceability of the product needs to be maintained to enable the history of a batch, so in case of deviation, the batch can be retained comprehensible and accessible form.
The system must be robust in place for recalling any batch from sale or supply.
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Along with GMP other good practices exist :
How to get GMP Certification?
For the improvements in the business model and to acquire more clients it is advisable to get certified. To get quick and hassle-free GMP Certification then why waiting, follow the below Steps and start your business progress now.
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Training and Implementation
Audits and Documentations
Certification and Payment
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