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Importance of Qualified Persons in Pharmaceuticals


Now drug manufacturers must have comply their manufacturing facility for GMP/GLP and employee must be certified and trained for the area they are deployed.
Qualified and trained employees are the keys to manufacture the good quality product. Every step of pharmaceutical manufacturing and analysis should be done by the competent person. All regulatory agencies have their guidelines for qualified persons and their training.

FDA follows 21CFR 211.25 guidelines for qualified personnel stating that the personnel involved in drug manufacturing, processing, packing or holding must be qualified, trained and experienced in drug manufacturing. Training should be given on the particular operation and current good manufacturing practices as related to the employee’s work.
Qualified Person

Recently Central Drug Standards Control Organization (CDSCO) has announced to employ the qualified and trained person in pharmaceutical manufacturing units to improve the skills of the pharmaceutical professionals. It will help to improve the quality of Indian pharmaceutical products. Now government want to improve the quality of pharmaceutical products in domestic market also. There is a gap between quality of products sold in domestic and international market that should be filled by improvement in product quality.

Drug Controller General of India (DCGI)- Dr. G N Singh says "No person shall be employed in any pharmaceuticals/ biopharmaceutical manufacturing units unless he has obtained a formal diploma or degree in the relevant area, or has been certified." January 1, 2018 is deadline to complete the certification process for the drug manufacturing companies. This notice is posted on CDSCO website. Personnel must have the diploma or degree in the relevant area or must be certified by the Life Sciences Sector Skill Development Council or any equivalent agency. Companies have to take the necessary steps to ensure that the employees are certified and trained for the respective areas.

CDSCO also ordered the companies to do their self assessment for the compliance of the good manufacturing practices (cGMP) and good laboratory practices (GLP). They have provided a compliance checklist to perform the GMP/GLP evaluation. Checklist is prepared to fulfil the GMP requirements of Schedule M, Schedule L-1, WHO and PIC/s standards. GMP/GLP checklist must be complied, filled and submitted to office of DCGI by November 15, 2016 by all drug manufacturers as per the notice. Checklist is prepared to evaluate and rate the manufacturing site for the risk they are posing to the patients by their nature of working or product quality.

From last few years Indian pharmaceutical products are facing problems in US and other regulatory markets due the product quality or improper documentation and data integrity. A number of companies like Wockhardt, Dr. Reddy's Laboratories, Ranbaxy Laboratories, Cadila Healthcare and IPCA Laboratories are banned or got warning letters from US-FDA.

India is an important player in international pharmaceutical market, manufacturing about 40% of the generic drugs prescribed in US. These negative news has undermined the credibility of Indian pharmaceutical sector. Last year in 2015 a slowdown in Indian pharmaceutical sector is seen due to these bans and poor product quality.

This move of CDSCO shall force the pharmaceutical manufacturing units to have qualified and competent persons. This will improve the quality of Indian pharmaceutical products. We are also writing from last 8 years on different cGMP topics for the pharmaceutical professionals to improve their skills and quality of pharmaceutical products. Add your views about this in comment section.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


1 Comment so far : Add yours...

Jitumani Barman said...

Qualified and competent candidate can only bring high productivity to the organisation

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