The Risk-Based Joint Inspection of CDSCO in Pharma refers to a strategic approach to pharmaceutical inspections conducted by the Central Drugs Standard Control Organization (CDSCO) in collaboration with state regulatory authorities. Here’s a breakdown:
Actions taken based on inspection findings can range from issuing compliance reports to stop production orders and license cancellations.
Purpose:
The primary goal is to ensure the quality, safety, and efficacy of pharmaceutical products manufactured in India.
It aims to optimize regulatory resources by focusing on facilities that pose the highest risk to public health.
It strengthens regulatory oversight of drug manufacturing and testing firms.
Risk-Based Approach:
Instead of routine, uniform inspections, this method prioritizes inspections based on risk factors. These factors can include:
The manufacturer’s compliance history.
The type of drugs produced (e.g., high-risk drugs like narcotics).
The complexity of the manufacturing process.
Information related to complaints or quality defects.
This allows the CDSCO and state regulators to concentrate their efforts on facilities with a higher likelihood of non-compliance.
Joint Inspections:
These inspections involve teams comprised of officials from both the CDSCO and the respective state drug regulatory authorities.
This collaborative approach promotes uniformity in enforcement and leverages the expertise of both central and state regulators.
Key Aspects:
Focus on Good Manufacturing Practices (GMP) compliance.
Evaluation of quality systems and infrastructure.
Emphasis on areas posing significant public health risks.
The use of guidance documents to provide uniform enforcement procedures.
This part contain the information of pharmaceutical organization.
As per the said direction, the SOP and checklist benchmarking tool available at CDSCO website under public notice vide F.No. DCGI/Misc/2016(60) dated 26/05/2016 is used for the inspection purpose. The details are reported here under:This
Name of the Manufacturing Unit: Mention the name of Maufacturing unit
Address of the Manufacturing Unit: Mention the address of site
Mfg. Lic. No.: Mention the Lic. No. of site
Validity of License: Mention the validity of lic.
Constitution of the firm: Its a set of legal documents that define the company’s governance, powers, and limitations. It’s a legally binding agreement between the company and its members.
List of Directors/ Partners/ Proprietor: List of director should be available
License Issuing Authority: Mention the License issuing authority
Categories of drugs permitted to be manufactured: Mention the catagory of manufactured drugs
Specify whether COPP has been issued to the firm: Specify
Name and Designation of the Inspecting team members: Name of inspector
Site Specific Data: Metioned it
No. of Products manufactured at site (during last year): Product List should be available
No. of manufacturing blocks: Detail should be available
No. of Technical Personnel in Manufacturing: A list of technical staff should be available
No. of Technical Personnel in QA: A list of QA staff should be available
No. of Technical Personnel in QC: A list of QC staff should be available
No. of Technical Personnel in Microbiology: A list of Microbiology staff should be available
No. of Technical Personnel from another Department: A list of technical staff should be available
No. of Technical Personnel in R&D: A list of R&D staff should be available
No. of technical personnel in Formulation development: A list of F&D staff should be available
No. of Samples drawn by QC (during last year): Should be available in QC
No. of Samples declared OOS (during last year): OOS register should be avialble
No. of samples declared NSQ by Govt. Analyst (during last five year). Collect reasons for such failures and annexe with this checklist: List should be availble.