CDSCO Inspection Checklist for Manufacturing Sites

The CDSCO inspection checklist for manufacturing sites plays an important role that drug and medical device factories in India follow legal, quality, and safety standards. By checking if manufacturers are following legal requirements and good manufacturing methods, these inspections, which are carried out by the CDSCO, directly contribute to the protection of public health. This article will explain what an inspection is, when it takes place, what it looks for, and how to be completely ready for it.  

What is A CDSCO Inspection for Manufacturing Sites?

The CDSCO formally inspects production sites to ensure that a facility producing drugs or medical devices complies with all quality, safety, and regulatory requirements set forth by Indian law.

Purpose of the CDSCO inspection:

• The manufacturing process is safe and consistent
• The product meets Indian Quality Standards
• The site is following good manufacturing practices (GMP)
• There is no risk to patient safety

Why Is CDSCO Inspection Important For Medical Device or Drug Manufacturing Sites?

CDSCO Inspection is important because it assures that medical devices or drugs are safe, effective, and made under proper conditions. It checks for compliance with quality standards, good manufacturing practices (GMP), and all applicable laws. This safeguards public health and increases consumer confidence in the Indian product. 

• Regulatory Approvals 
• Market Access
• Risk Control
• Global Recognition

When Does CDSCO Conduct Inspections at Manufacturing Sites?

CDSCO conducts inspections at manufacturing sites under specific situations to ensure that the facility is following proper safety, quality, and legal standards. 

• For Post-Licensing Surveillance – Even after the license is issued, CDSCO conducts regular or surprise inspections to ensure the manufacturer continues
• Upon receiving a Complaint – If a complaint is raised against a company, like product failure, contamination, or side effects, CDSCO may immediately inspect the facility to investigate the issue
• Before Product Approval For Import/Export – In some cases, if the company wants to export or import regulated drugs or devices, CDSCO may inspect to check if international quality standards are being followed.
• During GMP Certification or a WHO GMP Inspection – When a company applies for a GMP Certificate, CDSCO performs a Detailed Audit to ensure the site meets all requirements.  

Who Conducts the CDSCO Inspections at Manufacturing Facilities?

CDSCO inspections at manufacturing facilities are conducted by Drug Inspectors, Medical Device Officers, or officials authorized by CDSCO. These officers are trained professionals who check if the facility follows all required rules under the Drugs and Cosmetics Act, 1940, and related regulations. In some cases, a team of inspectors from both CDSCO and state Drug Control Authorities may conduct a joint inspection for better evaluation. 

What is Included in the CDSCO Inspection Checklist for Manufacturing Sites?

To make sure a production facility is adhering to all safety, quality, and regulatory requirements, inspectors utilize the comprehensive CDSCO inspection checklist for manufacturing sites. The checklist addresses every important aspect that influences product safety and regulatory compliance, regardless of whether it is a production facility for pharmaceuticals or medical devices. 

• Manufacturing Facility & Premises – Cleanliness and hygiene of the premises, proper segregation of areas, ventilation, and air control system.
• Equipment & Machinery – Proper installation and maintenance of machines, calibration and validation records, equipment cleaning logs, and use of qualified tools for each process.
• Documents & Records – Batch manufacturing records, standard operating procedure, product recall records, training records of employees, and quality control and quality assurance documentation. 
• Raw Materials & Finished Products – Source and quality raw material, storage conditions, testing of finished goods before release, and re-test tracking.
• Quality Control Lab – In-house testing capabilities, stability testing and validation, calibration of lab requirements, and qualified technical staff.

How To Prepare For a CDSCO Inspection at a Manufacturing Site?

You must prepare for the CDSCO inspection checklist for manufacturing sites as it is important to ensure that your site meets all regulatory and quality standards. Check the points to get it in a better way:

• Understand the Inspection Scope
• Maintain Complete Documentation
• Review Quality Control System
• Check Facility Hygiene & Layout
• Train Your Staff
• Conduct Internal Audits
• Review Safety Measures 
• Appoint a Compliance Coordinator

Documents Required During a CDSCO Inspection

Here we have listed the important documents required for CDSCO inspection for manufacturing sites:

• Manufacturing License
• Product Registration Certificate
• Import License
• Site Master File
• Device Master File
• Copy of GMP Certificate
• Quality Policy and Objectives
• Quality Manual 
• SOPs
• Internal Audit Reports & Corrective Actions
• CAPA (Corrective and Preventive Action)
• Change Control Records
• Product Recall Procedure 
• Validation Master Plan
• Previous CDSCO or State FDA Inspection Reports
• Response Letter & Action Taken Reports
• Self-Inspection Reports

Are There Any Safety or Hygiene Checks in The CDSCO Inspection Checklist for Manufacturing Sites?

Yes, safety and hygiene checks are an important part of the CDSCO inspection checklist for manufacturing sites. During the inspection, CDSCO officials check whether the manufacturing site follows proper cleanliness, hygiene, and worker safety measures. This includes:

• Clean and sanitized production area
• Proper handwashing stations and hygiene gear
• Regular cleaning and pest control records
• Safe storage of raw materials and finished products
• Waste disposal systems that don’t affect product safety
• Employee health checks and hygiene

Does CDSCO Inspect Equipment and Production Process Too?

Yes, CDSCO also inspects equipment and the production process during the site inspection.  They usually check if the machines used for manufacturing are:

• Well-maintained and calibrated regularly
• Clean and suitable for the type of product being made
• Operated by trained staff

What Are The Common Mistakes That Lead to CDSCO Inspection Failures?

Failing a CDSCO inspection usually happens because of carelessness, lack of preparation, or not following proper rules. Below, we have mentioned all the mistakes that manufacturers made:

• Missing or Incomplete Documentation
• Non-Compliance with GMP
• Improper Equipment Maintenance
• Lack of Trained Staff
• Unapproved Product or Process Changes
• Safety & Hygiene Issues
• Incorrect or Incomplete Labeling
• Failure in Quality Control
• No Internal Audit or Mock Inspections

Why Choose ELT Corporate for CDSCO Inspection For Manufacturing Sites?

Getting ready for a CDSCO inspection can be stressful and technical, but it doesn’t have to be. At ELT Corporate, we make the entire process smooth, compliant, and stress-free for you as a regulatory consultancy. Here we offer:

• Expert Consultation
• Pre-Inspection Audit Support
• Document Preparation
• GMP & Compliance Training
• Labeling & Product Registration Helps
• Post Inspection Support
• 10+ Years of Industry Experience
• Fast, Reliable, and Professional Services

Do you have more queries? Don’t worry, we are just a call away. Dial 9891998002 to get all the details, or directly email at info@medicaldeviceregistration.com.