GMP Certification in Bangalore

Listing ID #1794966

GMP stands for Good Manufacturing Practices. GMPs are guidelines that provide a system of processes, procedures and documentation to assure that the product manufactured has the identity, strength, composition, quality and purity that appear on the product label. We have proven to each of these certifying organizations that our manufacturing operations meet or exceed all of their very strict standards. The WHO GMP certification means quality management system driven by PQ certification application has achieved all-around promotion, oral preparation production line has reached international standard and factory's software and hardware have reached domestic advanced level. The PQ project has trained many talented people in different field, provided rich human resources reserve, and serves as a milestone before Duo-Cotecxin finally being authorized with PQ certification.

Principles of GMP Compliance Certificate:

1. Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.

2. Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.

3. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

4. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.

5. Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)

6. Operators are trained to carry out and document procedures.

7. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected.Deviations are investigated and documented.

8. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.

9. The distribution of the drugs minimizes any risk to their quality.

10. A system is available for recalling any batch of drug from sale or supply.

11. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

CDG Certification Ltd. counted among the leading firms that are engaged in rendering services for ISO 9001 Certification Services.

CDG offering a wide range of GMP Certification Services. Good manufacturing practice GMP is required being adopted in the manufacturing of pharmaceuticals or drugs, active pharmaceutical ingredients, diagnostics, foods and medical devices. GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product.