cGMP Compliant Manufacturing Facility
Current Good Manufacturing Practice (cGMPs) regulation is a primary regulatory standard for ensuring quality in pharmaceuticals. cGMP is enforced by the US Food and Drug Administration (FDA) and adherence to these important regulations is a necessity. cGMPs ensure the quality of drug products in all aspects. Several regulatory actions are taken by FDA against drug manufacturers if they lack cGMPs.
Good Manufacturing Practice (GMP) covers all aspects of production from the start to the end, including premises and equipment at a drug manufacturing company. Training and personal hygiene of the staff is also covered under this regulation. Detailed procedures are required for each process to ensure the optimum quality of the final product. GMP calls for documented proof of correct procedures at each step in the manufacturing process.
Laws that can incur criminal penalties if not followed:
- 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Of Drugs; General Part
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- 21 CFR Part 600 – Biological Products: General
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
In addition, there are several additional laws that may be required for your product.
Not complying with GMP guidelines can be expensive and risky for companies dealing in medicines and drugs. In fact, failure to comply can also lead to FDA’s disapproval of an application to market a drug. All prescription and OTC products available for use in the US must now be produced according to the FDA’s cGMP regulations.
CarlsbadTech has a fully cGMP-compliant manufacturing facility. This means that we have demonstrated a strong regulatory compliance of international standards. As a cGMP-compliant manufacturing facility, we carry out manufacturing, packaging and marketing of drugs with adherence to cGMP guidelines. We ensure that our product meets cGMP regulations in each and every aspect. For products manufactured in other cGMP facilities that are affiliated with Carlsbad, Carlsbad’s QA team regularly audits such affiliated facilities.
CarlsbadTech is one of the pioneers in the medical and pharmaceutical field and our cGMP-compliant manufacturing facility is among the best in the industry today. Our globally recognized facility aims at providing the highest level of safety and efficacy of drugs, food and health products, medical devices and much more.
Contact us today for the finest services in the pharmaceutical regulatory and advisory domain.