Pharmaceutical Company in Ahmedabad
Pharmaceutical Company in Ahmedabad
Welcome to our pharmaceutical company website! We are a leading
dedicated to developing and manufacturing high-quality, affordable, and innovative medicines to improve the health and well-being of people around the world.
Quality and trained employees are the keys to producing good quality products. Every step of manufacturing and pharmaceutical analysis must be carried out by competent people. All supervisory bodies have their rules for qualified people and their training.
As a leading
The FDA adheres to 21CFR 211.25 guidelines for eligible personnel stating that personnel involved in making drugs, processing, packing or holding must meet the requirements, trained and experienced in making drugs. Training must be given to certain operations and good manufacturing practices today related to employee work.
Recently the central medicine standard control organization (CDSCO) has announced to employ qualified and trained people in the pharmaceutical manufacturing unit to improve the skills of pharmaceutical professionals. This will help to improve the quality of Indianpharmaceutical products. Now the government wants to improve the quality of pharmaceutical products in the domestic market as well. There is a gap between product quality sold in the domestic and international markets that must be filled by improving the quality of the product quality.
Drug Controller General India (DCGI) - Dr. G N Singh said, "No one will be employed in each pharmaceutical / biopharmaceutical manufacturing unit unless he has obtained a Diploma or a formal degree in the relevant field, or has been certified." January 1, 2018 is the deadline for completing the certification process for drug manufacturing companies. This notification was posted on the CDSCO website.
Personnel must have a diploma or degree in a relevant field or must be certified by the Skills Development Board or equivalent body. The company must take the steps needed to ensure that employees are certified and trained in each field.
CDSCO also ordered the company to conduct its own assessment for good manufacturing practices (CGMP) and good laboratory practices (GLP). They have provided a checklist of compliance to conduct GMP / GLP evaluations. Checklist Prepared to meet GMP Schedule M requirements, L-1 schedule, which and Standard PIC / S. The GMP / GLP checklist must be compiled, filled and sent to the DCGI office on November 15, 2016 by all drug manufacturers according to notifications. Checklists are ready to evaluate and assess manufacturing sites for risks they pose for patients with the nature of their working or product quality.
Of the last few years, Indian pharmaceutical products face problems in the US and other regulated markets due to improper product quality or documentation and data integrity. Some companies such as Wockhardt, Dr. Laboratory Reddy, Sun Pharmaceutical, Cadila Healthcare and IPCA laboratories are prohibited or received a warning letter from the US-FDA.
India is an important player in the international pharmaceutical market, which produces around 40% of generic drugs prescribed in the US. This negative news has damaged the credibility of the Indian pharmaceutical sector. Few years back in 2015 a slowdown in the Indian pharmaceutical sector was seen because of this ban and poor product quality.
This CDSCO step will force pharmaceutical manufacturing units to have quality and competent people. This will ultimately improve the quality of Indian pharmaceutical products.
Rhombus Pharma Pvt Ltd is following all the parameters to fulfil the quality standard defined by the health care bodies and this ultimately leads to the good consumer compliance and this is how
Rhombus Pharma Pvt Ltd
