Checklist for Audit in Sterile Area

Checklist for Audit in Sterile Area

Checklist to verify the sterile manufacturing area before the audit.

1. Is there any SOP giving details for activity/ movement in the sterile area.

2. Verify the suitability of system for sanitization of hands.

3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available?

4. Verify the availability of following records: Air pressure differential Particulate monitoring Temperature Humidity Microbiological monitoring by settle plate

5. Are these records available and maintained as per SOPs?

6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs.

7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person?

8. Are the location for settle plates identified and the chart/ layout available with plant?

9. Are the following areas monitored for parameters mentioned in step 4: Air-lock to the critical area Critical area Controlled area Entrance in control area

10. Check the change room number 2 as per class?

11. Is there any environmental monitoring carried out in this area?

12. Is there any record maintained for cleaning in this area?

13. Check separate space specified and identification for fresh inner garment and used garment?

14. Check disinfectant solution must bear ‘use before’ label?

15. Is there any airlock between class D area and unclassified area?

16. Is there any interlocking provided to avoid contamination?

17. Is there any SOP to prepare the disinfectant solution in this area?

18. Is there any environmental monitoring carried out to maintain class D?

19. Is there any record maintained for monitoring the area at a particular frequency?

20. Is any microbiological monitoring carried out in this area?

21. Is any personnel monitoring carried out in class D?

22. If Yes- are the results recorded?

23. Is any cleaning record maintained for class D area?

24. Is cleaning procedure validated?

25. Is there any drainage sink in class D area?

26. Is there any sop for sanitize the sink, drainage?

27. Check the differential pressure of area is under specification limit

28. Check the door they must be closed automatically by pressure?

29. Is there any airlock provided between unclassified area and class D area for receiving raw material?

30. Is there any interlocking provided in airlock.

31. Is there any insectocutor outside the airlock?

32. Is there any air curtain outside the door?

33. Is there any sop to bring Al .container, sampling aid, rubber stopper from unclassified area to class D area?

34. Is there any sop for cleaning the container

35. Check the cracks, crevices, hole in wall, ceiling floor.

36. Is there any sop for cleaning the sterilizer

37. Is there record maintained for its operation

38. Is the adopted method for sterilization validated?

39. Check loading pattern displayed

40. Is any SOP prepared for cleaning the dry heat sterilizer?

41. Is there loading pattern displayed

42. Is the adopted method for sterilization in DHS validated?

43. Is there any SOP for cleaning, sterilization for cartridge filter?

44. Is the adopted method for sterilization validated?

45. Is any computerized facility provided for sterilization?

46. Is computerized equipment validated?

47. Is there any pass box between the controlled area and aseptic area?

48. Is there any SOP for handling pass box?

49. Is adopting process validated for pass box?

50. Is any environmental monitoring carried out for it?

51. Is any microbiological monitoring carried out and recorded?

52. Is there any record for UV light replacement in pass box?

53. Check the differential pressure of various location of aseptic area. Are they under specification?

Comments

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...

MSDS (Material Safety Data Sheet)

MSDS What Is an MSDS? An MSDS (Material Safety Data Sheet) is a document that provides detailed information about a chemical substance, including its hazards, safe handling procedures, storage requirements, and emergency measures. Today, MSDS is more commonly called SDS (Safety Data Sheet) under the Globally Harmonized System (GHS). Why MSDS / SDS Is Important Protect workers and employees Ensure safe handling and storage of chemicals Prevent accidents and injuries Provide emergency response information Comply with workplace safety regulations. MSDS (Material Safety Data Sheet) International safety standards. GHS – Globally Harmonized System Full form: Globally Harmonized System of Classification and Labelling of Chemicals Develop by United Nations (UN). OSHA (USA) – Hazard Communication Standard (HCS) Factories Act & Chemical Rules (India) Factories Act, 1948 Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 REACH (Europe) REACH Regula...

Steps for HPLC Method Development

Steps for HPLC Method Development Know about the different steps of the HPLC analytical method development in pharmaceutical analysis. Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, used column, mobile phase and buffer should be common. It can be done easily step by step. Following are the common HPLC method development steps. 1. Selection of HPLC Analytical Method 2. Selection of Chromatographic Conditions 3. Parameter Optimization 1. Selection of HPLC Analytical Method: First of all consult the literature that is available on the product. It will help you to understand the nature of the product that will help to select the different parameters. A. Sample Preparation: Select method to prepare the sample according to its ...

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture sterile pharmaceutical products as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the FFS and BFS is to reduce the contamination by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...

Pharmaceutical Guidelines

Search This Blog