The Fourth and Fifth Schedule Audits, conducted by either a Notified Body or the Central Licensing Authority (CLA), are essential steps in the process of obtaining a manufacturing license for medical devices in India under the Medical Device Rules (MDR) 2017. Let’s delve into each of these audits:
Who Are Notified Bodies?
Notified Bodies are independent organizations designated by the Indian government to assess the conformity of medical devices with the relevant regulations. They play a crucial role in the regulatory framework for medical devices in India.
Fourth Schedule Audit
- Scope: The Fourth Schedule Audit focuses primarily on the documentation submitted by the manufacturer as part of their license application. It assesses the completeness, accuracy, and compliance of these documents with the MDR 2017 requirements.
- Purpose: The Fourth Schedule Audit ensures that the manufacturer has a well-documented quality management system (QMS) in place and that their proposed manufacturing processes and facilities align with the regulatory requirements.
- Conducted by: This audit can be performed either by a Notified Body (for Class A and B devices) or by the CLA (for Class C and D devices).
- Documents Assessed:
Covering Letter: A formal letter requesting the license, along with details of the manufacturing site and the medical devices to be manufactured.
Form 27: This is the application form for a manufacturing license. It requires comprehensive information about the applicant, the manufacturing site, and the proposed activities.
Schedule D(I):
Schedule D(I) is a comprehensive list that the manufacturer needs to submit as part of their application. This list must include details about every medical device that the manufacturer intends to manufacture at the licensed premises.
Contents of Schedule D(I)
The following information is typically required in Schedule D(I):
- Name of Medical Device: The generic name or trade name of the medical device.
- Model Number/Variant (If Any): If there are different models or variants of the device, they should be listed separately with their respective model numbers.
- Class of Medical Device: The risk classification of the device as per the MDR 2017 (Class A, B, C, or D).
- Intended Use: A brief description of the intended use of the medical device.
- Materials of Construction: The materials used to manufacture the device (e.g., stainless steel, silicone, etc.).
- Shelf Life (If Applicable): If the device has a defined shelf life, it needs to be specified.
- Sterilization Method (If Applicable): If the device requires sterilization, the method of sterilization (e.g., Ethylene Oxide, Gamma radiation) needs to be mentioned.
- Packaging Details: The type of packaging to be used for the device.
- Labeling Details: Key information that will be included on the device label, such as the manufacturer’s name and address, device name, model number, batch/lot number, manufacturing date, expiry date (if applicable), and instructions for use.
- Any Other Relevant Information: Any additional information that the manufacturer deems relevant for the specific medical device.
Fee Challan: Proof of payment of the prescribed license fee.
Ownership Details: Documents establishing the ownership of the manufacturing site (e.g., sale deed, lease agreement).
Layout Plan: A detailed architectural plan of the manufacturing site, including the layout of various areas like production, storage, quality control, etc.
- List of Equipment: A comprehensive list of all equipment to be used in the manufacturing process, including their specifications and intended use.
- List of Measuring Instruments: A list of all measuring instruments to be used for quality control, including their calibration certificates.
- Process Flow Charts: Detailed flowcharts outlining the manufacturing process for each medical device.
- Quality Manual: A document detailing the manufacturer’s quality management system, including policies, procedures, and organizational structure.
- Stability Study Protocols & Data (if applicable): If the stability of the medical device is a concern, relevant study protocols and data need to be provided.
- Validation Protocols and Reports: Documents validating critical manufacturing processes, cleaning procedures, and sterilization methods.
- No Objection Certificate (NOC) from the State Pollution Control Board: This certificate ensures that the manufacturing activities comply with environmental regulations.
- Non-Resemblance Certificate: A certificate stating that the proposed medical device does not resemble any existing patented product.
- Affidavit of Non-Conviction: An affidavit from the manufacturer stating that they have not been convicted of any offense under the Drugs and Cosmetics Act or any other law related to the manufacture or sale of drugs or medical devices.
Fifth Schedule Audit
- Scope: The Fifth Schedule Audit involves a physical inspection of the manufacturing site to verify that it meets the infrastructure, equipment, and personnel requirements outlined in the MDR 2017.
- Purpose: The Fifth Schedule Audit verifies that the manufacturing site is capable of producing medical devices of consistent quality and safety in compliance with the regulatory standards.
- Conducted by: This audit is usually performed by a Notified Body (for Class A and B devices) or by the CLA (for Class C and D devices).
- Aspects Assessed:
Premises:
- Adequate space for various manufacturing activities, including production, storage, quality control, and administrative functions.
- Proper segregation of different areas to prevent cross-contamination.
- Controlled environment conditions (temperature, humidity, air quality) as per the requirements of the specific medical devices.
Equipment:
- Suitable equipment for all stages of the manufacturing process, including production, packaging, and labeling.
- Properly maintained and calibrated equipment to ensure consistent product quality.
Personnel:
- Qualified and trained personnel for all manufacturing activities.
- Adequate staffing levels to handle the production volume.
- Medical Health Checkup Records
Utilities:
- Reliable supply of electricity, water, and other utilities necessary for the manufacturing process.
- Backup systems to ensure uninterrupted operation in case of power failure or other disruptions.
Storage:
- Adequate storage space for raw materials, in-process materials, finished products, and rejected materials.
- Proper storage conditions (temperature, humidity) to maintain the quality and integrity of the products.
Quality Control:
- Dedicated quality control laboratory with necessary equipment and trained personnel.
- Implementation of robust quality control procedures at all stages of the manufacturing process.
Safety:
- Adequate fire safety measures, including fire extinguishers, fire alarms, and emergency exits.
- Safety equipment and procedures to protect workers from hazards associated with the manufacturing process.
- Pest Control Records & Agreement.
Key Points:
- Joint Audits: In some cases, the Fourth and Fifth Schedule Audits may be conducted jointly, combining the document review and site inspection.
- Non-Conformities: If any non-conformities are identified during the audit, the manufacturer must take corrective actions to address them before the license can be granted.
- License Validity: Once the manufacturing license is granted, it is typically valid for a period of five years, subject to continued compliance with the MDR 2017.
- The specific requirements may vary depending on the risk classification of the medical device (Class A, B, C, or D). Higher-risk devices may require more stringent documentation and site requirements.