SOP for Reduced Testing

SOP for Reduced Testing

Standard operating procedure to reduce the testing of raw materials to increase the speed of testing and productivity of quality control department.

1.0 PURPOSE

To define the procedure for releasing the materials after reduced testing.

2.0 SCOPE

This procedure is applicable to raw material testing carried out in quality control.

3.0 RESPONSIBILITIES

3.1 Analyst

3.1.1 To check the integrity of the consignment at the time of sampling.

3.1.2 To ensure approved COA of the manufacturer should available.

3.1.3 To carry out reduce testing as per SOP.

4.0 ACCOUNTABILITY

4.1 Head QC or Designee

4.1.1 To ensure the documentation as per SOP.

4.1.2 To ensure that analysis carried out as per SOP while apply the reduce testing.

5.0 PROCEDURE

5.1 Same Batch

5.1.1 If the material of the same batch no. received within two months from the same manufacturer, the analyst shall check the integrity of thecontainer, approved COA of the manufacturer, and other details as per the GIM against the “QUARANTINE” label.

5.1.2 If all above parameter found satisfactory, the analyst shall sample the material as per the general sampling procedure for raw material.

5.1.3 Material shall be analyzed for critical tests which are specified as “(**)” in the respective specification.

5.1.4 If material complies with critical tests, the material shall be released on the basis of previous analysis.

5.2 OVI and Residual Solvent

5.2.1 If manufacturer’s COA comply with the specification for OVI/ residual solvents tests than the material can be released on the basis ofmanufacturer’s COA.

5.3 Reduce Testing based on Trending

5.3.1 Reduce testing shall be allowed after the satisfactory analysis/trending in the following cases.

5.3.1.1 Raw materials which have completely analyzed and approved for consecutive five times of the same vendor.

5.3.1.2 In case the vendor is approved from the regulated agency than raw materials, which have completely analyzed and approved for consecutivethree times of the same vendor.

5.3.2 After generation of above data raw material shall be analyzed for critical tests which are specified as “(**)” in the respective specification.

5.3.3 If material complies with critical tests, the material shall be released.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure

6.2 COA: Certificate of Analysis

6.3 OVI: Organic Volatile Impurities

6.4 QC: Quality Control

Comments

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 ar...

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...

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