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Ensuring Drug Safety and Quality: A Comprehensive Guide



  Aug 07, 2023

Drug Safety and Quality


Good Manufacturing Practices (GMP) for Pharma Companies in India

 

Q1: What is Good Manufacturing Practices (GMP)?

A1: Good Manufacturing Practices (GMP) is a set of quality assurance and control guidelines that ensure pharmaceutical products are consistently produced and controlled to meet the required quality standards.
 

Q2: Why is the Indian government requiring pharma companies to obtain a GMP certificate?

A2: The Indian government has mandated the GMP certificate to ensure the production of high-quality and safe pharmaceutical products. This move comes in response to concerns raised by the World Health Organization (WHO) about the safety of some cough syrups sold overseas.
 

Q3: What is the timeframe given to pharma companies to obtain the GMP certificate?

A3: Pharma companies, including MSMEs (Micro, Small, and Medium Enterprises), with an annual turnover of less than ₹250 crore, have 12 months to complete the certification process. Those with an annual turnover of over ₹250 crore must complete it within 6 months.
 

Q4: What are the consequences of not obtaining the GMP certificate?

A4: Failure to obtain the GMP certificate will result in the suspension of manufacturing activities, withdrawal of licenses, and financial penalties.
 

Q5: What are some of the key requirements under the GMP certification process?

A5: The GMP certification process involves adherence to requirements such as pharmaceutical quality systems, quality risk management, product quality reviews, equipment qualification and validation, change control management, self-inspections, and stability studies.
 

Q6: When were GMP guidelines first introduced in India?

A6: GMP guidelines were first incorporated in Schedule M of the Drugs and Cosmetics Rules in 1988, with the last amendment in June 2005.
 

Q7: How many pharma manufacturers in India currently have a GMP certificate?

A7: Out of the 10,500 manufacturers in India, including MSMEs, only 2,000 (mainly exporters) currently possess a GMP certificate.
 

Q8: How does the GMP certification benefit the pharmaceutical industry and consumers?

A8: GMP certification ensures that pharmaceutical products are manufactured with consistent quality and safety standards, providing consumers with reliable and safe medications. It also enhances the reputation of the pharmaceutical industry and promotes the export of high-quality products.
 

Q9: What are the major changes introduced with the new GMP regime?

A9: The new GMP regime introduces various improvements, including a pharmaceutical quality system, quality risk management, product quality reviews, equipment validation, change control management, self-inspections, supplier audits, and stability studies.
 

Q10: How does the government plan to help smaller pharma companies achieve GMP certification?

A10: The government will support smaller pharma companies, including MSMEs, by allowing them 12 months to transition to the new GMP regime, recognizing the importance of their role in the industry.


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