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GMP compliance (Good Manufacturing Practices)

GMP (Good Manufacturing Practices) is a standard defined by WHO (World Health Organization), Good Manufacturing Practices (GMP)/Compliance is a system for ensuring that products are consistently produced and controlled according to quality standards. It require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood bank take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time. Many countries have legislated that pharmaceutical and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that CORRESPOND with their legislation. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must MEET to assure that the products are of high quality and do not pose any risk to the consumer or public.

GMP covers all aspects of the manufacturing process including :

1- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
2- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
3- Instructions and procedures are written in clear and unambiguous language.
4- Operators are trained to carry out and document procedures
5- Records are made manually or by instruments during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
6- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
7- Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs
8- Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination
9- The manufacturing process is as has been prescribed to maintain the standardsbr /> 10- Adequate quality control measures are adopted










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NEWS

  • As part of updating its registry, MCA would be conducting KYC of all Directors of all companies annually through a new eform viz. DIR-3 KYC to be notified and deployed shortly. Accordingly, every Director who has been allotted DIN on or before 31st March, 2018 and whose DIN is in ‘Approved’ status, would be mandatorily required to file form DIR-3 KYC on or before 31st August,2018. While filing the form,the Unique Personal Mobile Number and Person

  • Forms MGT-7, AOC-4 and Additional Attachment are likely to be revised on MCA21 Company Forms Download page w.e.f 14th JULY 2018. Stakeholders are advised to check the latest version before filing.

  • DIR-3 KYC will be available on MCA21 Company Forms Download page w.e.f 14th July 2018 for filing purposes. Stakeholders are advised to plan accordingly.

  • MCA21 system will be intermittently unavailable from Saturday, 23rd June 2018 09.00 pm to Saturday, 23rd June 2018 11.00 pm IST due to maintenance activity. Stakeholders are requested to plan accordingly.

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