presentation on Auditing of capsule and sterile production.pptx1.pptx

Notes.

1. Mahatma   Gandhi   Vidyamandir’s   Pharmacy college Panchavati ,Nashik Pharmaceutical Quality Assurance Department Sub : Audit and Regulatory Compliance Prepared By Guided by Miss. Punam Uttam Borde Priyanka Chaudhari Mam Roll No: 37 Presentation on Auditing of capsule and sterile production MGV'S Pharmacy College Panchvati,Nashik 1

2. Vision ‘’ To be a Centre of professional excellence by contributing honestly to the pharmacist moulding process’’ Mission: Impart high quality education to graduates Contribute to all spheres of professional activities Uphold human values and ethics Nature them into globally competent professional MGV'S Pharmacy College Panchvati,Nashik 2

3. Content Introduction Auditing of Capsule Auditing of Sterile production references MGV'S Pharmacy College Panchvati,Nashik 3

4. Introduction: Audit: The term “audit’’ has been derived from the latin word “ audire ” which means “to here”. Hence ,an auditor is a person who here and listen. Auditing is defined as systematic and independent examination of data, statement, records, and performance(financial and otherwise) of an stated purpose. It is the on-site verification activity such as inspection or examination , of a process or quality system, to ensure compliance to requirement. MGV'S Pharmacy College Panchvati,Nashik 4

5. Auditor: an auditor is one who conducts an audit. specifically, an auditor is a person or firm that conducts a formal examination and verification of an individuals or organization records and accounts, finances, or compliance with a set of standards . Vendor: Vendor means a person (or company) who sell and suppliers his (or its) products. Vendor audit: A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor's quality management system, as well as its practices, products, and documentation to reduce cost and improve quality. MGV'S Pharmacy College Panchvati,Nashik 5

6. Benefits of vendor audit Cost saving Process improvement Risk reduction Relationship building Helps management to achieve objectives MGV'S Pharmacy College Panchvati,Nashik 6

7. Supplier audit checklist: Auditing suppliers are foundational in establishing strong customer-supplier relationships. Supplier audits aim to assess and promote smooth operations in key business areas such as manufacturing, engineering, invoicing, QA, and shipping. Supplier audit checklist is used to audit your supplier's facility, record if the supplier meets the criteria, and evaluate its suitability to be your supplier. MGV'S Pharmacy College Panchvati,Nashik 7

8. The checklist can serve as a guide(references) for the inspector to evaluate the following areas: Management Responsibility Infrastructure, Sanitation, and Maintenance Traceability and Crisis Management Control of Materials Handling, Storage, and Delivery Calibration, Measuring, and Test Equipment Food Safety and HACCP Systems Manufacturing Quality Systems Regulatory Compliance MGV'S Pharmacy College Panchvati,Nashik 8

9. Capsule: The term capsule is derived from the Latin word capsula , meaning a small container. Capsules are defined as unit solid dosage form of medicaments available as small containers (shells) made up of gelatin enclosing accurately measured drug substances Gelatin has the property of disintegrating when it comes in contact with water, thereby releasing the medicament completely. Instead, of gelatin, denatured gelatin, methyl cellulose and polyvinyl alcohol can also be used to make the capsule. MGV'S Pharmacy College Panchvati,Nashik 9

10. Audit of capsule: Manufacturing Equipment instrument calibration Packaging Packaging material Packaging operation Labels and labelling operation Reprocessing Finished product control Warehousing/distribution Environmental health and safety MGV'S Pharmacy College Panchvati,Nashik 10

11. Auditing of oral solid solution area : Verify equipment identified in the batch record against field equipment is the same, noting calibration and maintenance status. Determine if equipment is used for manufacturing more than one product. Determine that equipment is cleaned thoroughly by reviewing the equipment use, maintenance and cleaning log. Determine how cleaning is documented. Ensure that critical equipment is qualified according to the facility's established IQ/OQ procedure. Ensure that sterilization and cleaning has been validated. Review calibration status of balances MGV'S Pharmacy College Panchvati,Nashik 11

12. What should be audited : An oral solid or oral solution/suspension audit should include an examination of the all of the six GMP Systems: Quality Facility and Equipment QA Laboratory Material Handling Production Packaging and Labeling MGV'S Pharmacy College Panchvati,Nashik 12

13. Materials Receiving Area : Ensure that approved procedures are in place for inspection, sampling, testing and release of incoming materials (raw materials, packaging components, excipients, etc ). Confirm, through observation, that procedures are being followed. Determine if raw materials, intermediate products, or final products require special storage conditions or handling procedures. If special storage is needed, confirm that controls are in place to ensure these conditions are met throughout the holding, manufacturing, packaging, and distribution process. Review calibration status of balances in the weighing area. MGV'S Pharmacy College Panchvati,Nashik 13

14. Utility systems Determine what type of water is used in the process and in equipment cleaning. Determine if any compressed gases or other utilities are used in the manufacturing process. Ensure that if any utilities contact the product they have been qualified. Ensure that if filters are used in the process they have been qualified or validated according to the established approved facility procedures. Ensure that there are dust filters in place within the air system and that they are regularly maintained and recorded on a preventative maintenance schedule. Vacuum system. MGV'S Pharmacy College Panchvati,Nashik 14

15. Sterile product: The manufacture of sterile medicinal products is a complex activity that requires additional controls and measures to ensure the quality of products manufactured. ensure that all activities are effectively controlled so that all final products are free from microbial and other contamination. The manufacture of sterile products should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency. The various operations of component preparation, product preparation and filling should be carried out with appropriate technical and operational separation measures within the clean area. For the manufacture of sterile medicinal products 4 grades of clean room can be distinguished MGV'S Pharmacy College Panchvati,Nashik 15

16. Airlocks should be designed and used to provide physical separation and to minimize microbial and particulate contamination of the different areas, and should be present for material and personnel moving from different grades, typically airlocks used for personnel movement are separate to those used for material movement. The final stage of the airlock should, in the at-rest state, be the same grade as the area into which it leads. The use of separate changing rooms for entering and leaving clean areas is generally desirable) Personnel airlocks : A cascade concept should be followed for personnel In general hand washing facilities should be provided only in the first stage of the changing rooms Material airlocks : (used for materials and equipment). MGV'S Pharmacy College Panchvati,Nashik 16

17. Audit of Sterile products: Inspect the component preparation area. Ensure that sterilization equipment (autoclave, dry heat oven, sterilizing tunnel) has been validated and is properly maintained. Ensure that equipment used to wash/rinse containers and closures has been properly validated and maintained. Ensure the required water quality is used for washing/rinsing MGV'S Pharmacy College Panchvati,Nashik 17

18. Inspect the microbiology laboratory: Review sterility testing program, performance and test results. Review all investigations for completeness and lot disposition decisions. Determine if there are any trends regarding false positive test results and the root cause. Review the Media Fill Procedure: Ensure there is a defined, approved program. Ensure that the media fill program is compliant with the applicable regulations and site Policy/Guideline requirements. Ensure that all operators have participated in a media fill within the year. Ensure that media fills are performed for every aseptic filling line for every shift semi-annually MGV'S Pharmacy College Panchvati,Nashik 18

19. Ensure that all staff that might be involved in the aseptic filling process participates in the media fill. Review media fill performance documentation and all associated deviation reports. Ensure that the number of units filled during the media fill trial is equivalent to the number of units placed on incubation. Ensure that any variances in number are documented. MGV'S Pharmacy College Panchvati,Nashik 19

20. Review the Environmental Monitoring Program . Ensure that there is a defined, approved program. Review training records for staff performing program sampling and testing. Ensure that the program is compliant with all worldwide regulatory and site policy/guideline requirements. Ensure that there are established alert and action limits that are appropriate. Review test results and associated investigations. Ensure that the program requires review of test results prior to release of product batches. Ensure that data is tracked for trends and reviewed by QC unit on a regular basis. MGV'S Pharmacy College Panchvati,Nashik 20

21. Premises: Design & layout of facilities Plant safety & security Sanitation Personnel: Hygiene Staff qualification Staff training Validation: Validation of new master formula Validation of equipment and instrument Documentation: Labels Process Document SOP'S MGV'S Pharmacy College Panchvati,Nashik 21 Audit of sterile products:

22. References: http://www.slideshare.net/MittalRohit2/auditing-of-capsule-sterile-production-and-packaging ? http://www.mcrhrdi.gov.in/drugs/checklist/sterile.pdf http://www.mcrhrdi.gov.in/drugs/checklist/sterile.pdf https://d2evkimvhatqav..net/documents/pb auditing terminally sterilized drug product.pdf MGV'S Pharmacy College Panchvati,Nashik 22

23. Thank you MGV'S Pharmacy College Panchvati,Nashik 23