Importance of Qualified Persons in Pharmaceuticals

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 to the particular operation and current good manufacturing practices as related to the employee’s work.

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 the government wants to improve the quality of pharmaceutical products in domestic market also. There is a gap between the quality of products sold in the 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 the 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 in 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. The checklist is prepared to fulfill the GMP requirements of Schedule M, Schedule L-1, WHO and PIC/s standards. GMP/GLP checklist must be compiled, filled and submitted to the office of DCGI by November 15, 2016 by all drug manufacturers as per the notice. The 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 the US and other regulated markets due to the product quality or improper documentation and data integrity. A number of companies like Wockhardt, Dr. Reddy's Laboratories, Sun Pharmaceutical, Cadila Healthcare and IPCA Laboratories are banned or got warning letters from US-FDA.

India is an important player in the international pharmaceutical market, manufacturing about 40% of the generic drugs prescribed in the 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.