1. Purpose:
- To establish guidelines and procedures for conducting in-process control during manufacturing processes to ensure quality, consistency, and compliance with regulatory standards.
2. Scope:
- This SOP applies to all personnel involved in the manufacturing process, including operators, supervisors, and quality assurance personnel.
3. Responsibilities:
- Operators: Responsible for performing in-process control checks as outlined in this SOP.
- Supervisors: Responsible for overseeing the implementation of in-process control procedures and ensuring compliance with this SOP.
- Quality Assurance Personnel: Responsible for verifying the accuracy and completeness of in-process control documentation and providing oversight to ensure adherence to quality standards.
4. Materials and Equipment Required:
- Manufacturing equipment
- In-process control forms or checklists
- Measuring instruments (e.g., calipers, thermometers)
- Sampling tools (if applicable)
5. Procedure:
5.1 Preparation:
- Ensure that all necessary materials and equipment are available and calibrated before initiating in-process control.
- Verify that operators are trained on the procedures outlined in this SOP and understand the importance of in-process control in maintaining product quality.
5.2 In-Process Control Checks:
- Conduct in-process control checks at specified intervals during the manufacturing process, as outlined in the standard operating procedures for each respective process.
- Use appropriate measuring instruments to verify critical parameters such as dimensions, temperatures, pressures, and other relevant factors.
- Record the results of in-process control checks on the designated forms or checklists in real-time.
- If deviations from the predetermined specifications are observed, immediately notify the supervisor and quality assurance personnel for further investigation and corrective action.
5.3 Documentation:
- Complete all in-process control documentation accurately and legibly.
- Ensure that all required information, including date, time, operator’s name, and any observations or deviations, are recorded as per the established procedures.
- Sign and date the completed documentation to certify its accuracy and completeness.
5.4 Review and Approval:
- Supervisors or designated personnel must review the in-process control documentation to verify compliance with established procedures and specifications.
- Quality assurance personnel shall conduct periodic audits to ensure the effectiveness of in-process control measures and adherence to this SOP.
- Upon completion of the manufacturing process, ensure that all in-process control documentation is reviewed and approved before further processing or release of the product.
6. Training:
- Provide training to all personnel involved in the manufacturing process on the procedures outlined in this SOP.
- Conduct periodic refresher training sessions to reinforce the importance of in-process control and ensure ongoing compliance with established standards.
7. Records Retention:
- Maintain all in-process control records in a secure and organized manner as per the company’s document control procedures.
- Retain records for the specified retention period as required by regulatory standards and company policies.
8. Revision History:
- Document any revisions or updates made to this SOP and maintain a revision history log to track changes over time.
9. References:
- List any relevant documents, standards, or regulations referenced in the development of this SOP.
10. Definitions:
- Provide definitions for any terms or terminology used in this SOP to ensure clarity and understanding among personnel.
11. Approval:
- This SOP must be approved by the designated personnel responsible for quality assurance or regulatory compliance before implementation.
12. Distribution:
- Distribute copies of this SOP to all relevant personnel and ensure that it is readily accessible in the manufacturing area.
13. Implementation:
- This SOP shall be implemented immediately upon approval and communicated effectively to all personnel involved in the manufacturing process.
14. Monitoring and Compliance:
- Supervisors and quality assurance personnel shall monitor the implementation of this SOP to ensure ongoing compliance and effectiveness.
15. Non-Compliance:
- Non-compliance with this SOP may result in disciplinary action, retraining, or other appropriate measures as determined by management.
16. Review:
- Conduct periodic reviews of this SOP to assess its effectiveness and make any necessary updates or revisions to ensure continued compliance with regulatory standards and best practices.
17. Contact Information:
- Provide contact information for personnel responsible for administering this SOP and addressing any questions or concerns related to in-process control procedures.
- For more articles, Kindly Click here.
- For pharmaceutical jobs, follow us on LinkedIn
- For Editable SOPs in word format contact us on info@pharmaceuticalcarrier.com
- For more information kindly follow us on pharmaguidelines.co.uk
