sop for self inspection and internal audit for quality 1.0 OBJECTIVE: The objective of this SOP is: 1.1 To laid down the procedure to conduct self-inspection (Internal Audit) in order to monitor the implementation and compliance with Good Manufacturing Practices (GMP), Principles and to propose necessary corrective measures. 2.0 RESPONSIBILITY: 2.1 The … Read more
sop for area and equipment clearance procedure OBJECTIVE: 1.0 To describe the procedure for checking of equipment and area before giving line clearance during manufacturing and packaging operation. 2.0 RESPONSIBILITIES: 2.1 Quality Assurance – Officer/ Executive shall be: 2.1.1 Responsible for assuring the equipment and area for free from remnant of previous batch / … Read more
1.0 OBJECTIVE: The objective of this SOP is: 1.1 To describe a procedure for allowing transfer of Finished Goods under “Quarantined status” to our godown. 2.0 RESPONSIBILITY: 2.1 The Head – Warehouse shall be: 2.1.1 Responsible for raising the request for Quarantined Release. 2.2 Quality Assurance Officer shall be: 2.2.1 Responsible for verification and reconciliation … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for maintenance of equipment logbook. 2.0 SCOPE 2.1 This procedure is applicable to all equipment used in production sections . 3.0 RESPONSIBILITY 3.1 Concern Officer/Executive shall enter the operation and cleaning details in equipment log book. 3.2 Concern Officer/Executive shall execute this SOP. 4.0 ACCOUNTABILITY 4.1 Department Head … Read more
1.0 OBJECTIVE 1.1 To describe a procedure for Qualification of Outsource Testing Facility. 2.0 SCOPE 2.1 This procedure is applicable to testing the outsource qualification 3.0 RESPONSIBILITY 3.1 Executive – Quality Assurance Department. 4.0 ACCOUNTABILITY 4.1 Head – Quality Assurance. 5.0 PROCEDURE 5.1 Selection criteria 5.1.1 Outsource testing facility should have approved by any regulatory … Read more
1.0 OBJECTIVE: 1.1 To lay down the procedure for sampling, release and rejection of Packaging material 2.0 SCOPE: 2.1 This procedure is applicable for sampling, release and rejection of Packaging material 3.0 RESPONSIBILITY: 3.1 Executive/Officer/Chemist : Quality Control Department 4.0 ACCOUNTABILITY: 4.1 Head-QC (or) his designee/deputy 5.0 REFERENCE(S): 5.1 In-House 6.0 ENVIRONMENT, HEALTH AND SAFETY … Read more
PROCEDURE: 1.0 Description: Take 1 corrugated box from each container sampled and check visually the corrugated box as per specification and record the observations. Check the colour of the box as per specification. Check for the no. of ply and check whether box is properly closed or not. 2.0 Pasting: Check the pasting of the … Read more
1.0 OBJECTIVE 1.1 To lay down the detailed procedure for the Validation of Analytical Methods / Procedures. 2.0 SCOPE 2.1 This Procedure is applicable for the Validation of Analytical Methods being executed using Chromatographic Systems (For Assay, Related Substances, Residual Solvents, Chromatographic Purity, and Content Uniformity etc.), Rate, Particle Size, Viscosity etc. in the Quality … Read more
swab testing of various surfaces for bioburden determination 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for collection and testing of swabs of various surfaces for Bioburden determination in Microbiology lab. 2.0 SCOPE 2.1 This SOP is applicable for person taking the samples of swabs routine monitoring of aseptic area … Read more
gowning procedure for microbiological testing area 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for gowning as well as degowning of any sterile gown employed for aseptic areas. 2.0 SCOPE 2.1 This SOP is applicable for for gowning as well as degowning of any sterile gown employed for aseptic areas … Read more