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
sop for hplc column maintenance and washing 1.0 OBJECTIVE 1.1 To describe the procedure for the Maintenance, Column Washing and Usage Record of HPLC Column. 2.0 SCOPE 2.1 This SOP is applicable for the Maintenance, Column Washing and Usage Record of HPLC Column. 3.0 RESPONSIBILITY 3.1 QC Officer or QC Executive 4.0 ACCOUNTABILITY 4.1 … Read more
procedure for sampling and handling of bulk sample 1.0 OBJECTIVE 1.1 To lay down a procedure for the sampling & handling of bulk sample. 2.0 SCOPE 2.1 This procedure is applicable to the sampling & handling of bulk sample in manufacturing area. 3.0 RESPONSIBILITY 3.1 QC Officer or QC Executive 4.0 ACCOUNTABILITY 4.1 QC … Read more
STP for borewell generation point (raw water storage tank) PROCEDURE 1. Description : Take the sample and observe the colour and clarity visually Open the bottle and smell the odour. Take few ml of sample from the bottle and taste. Record the observations in the test protocol. 2. pH : Take 100 ml of … Read more