preparation of master formula record 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for numbering system for master formula record (MFR). 2.0 SCOPE 2.1 This SOP is applicable for numbering system for master formula record (MFR) 3.0 RESPONSIBILITY 3.1 Officer–Quality assurance-Prepare the SOP and follow-up the SOP accordingly 3.2 Asst. … Read more
sop for job responsibility 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for job responsibility of the employees with respect to their job and duties for work. 2.0 SCOPE 2.1 This SOP is applicable for employees with respect to their job and duties work 3.0 RESPONSIBILITY 3.1 Asst. Officer or … Read more
sop for Authorized Signatory 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the requirements for signature authorization for all document (i.e. master batch formula for processing and Packaging record, Batch manufacturing records, Validation protocols, Standard operating procedures, Finished & Intermediate product specifications & Standard testing procedures and Certificate of analysis etc) and … Read more
sop for preparation and standardization 0.1M Disodium Edetate 1. Preparation: Weigh accurately about 37.2g of disodium edetate and transfer to a 1000ml volumetric flask. Dissolve in sufficient purified water and make up to the mark with purified water. OR As per requirement (consumption history) prepare suitable amount of volumetric solution accordingly. 2. Standardization: Weigh … Read more
sop for Bioburden test of Packing materials in Microbiology Laboratory 1.0 OBJECTIVE 1.1 To lay down a procedure for Microbiological Content Test of Packing materials. 2.0 SCOPE 2.1 This procedure applicable for Bioburden test of Packing materials in Microbiology Laboratory 3.0 RESPONSIBILITY 3.1 Officer Microbiologist 3.2 Executive Microbiologist 4.0 ACCOUNTABILITY 4.1 Head –QC 5.0 PROCEDURE … Read more
sop for qualification of analyst microbiologist 1.0 OBJECTIVE 1.1 To describe the procedure for qualification of analyst. The purpose of this exercise is to ensure that the analyst is qualified for gowning procedure and sterility and bacterial endotoxin test prior performing the tests on regular basis. 2.0 SCOPE 2.1 This procedure is applicable for all … Read more
sop for receipt storage and Determining the population of Biological indicators 1.0 OBJECTIVE 1.1 To describe a procedure for receipt storage and Determining the population of Biological indicators. 2.0 SCOPE 2.1 This procedure applies receipt storage and Determining the population of Biological indicators in Microbiology laboratory 3.0 RESPONSIBILITY 3.1 Officer Microbiologist 3.2 Executive Microbiologist 4.0 … Read more
preparation and standardization 0.1M Sodium Hydroxide Solution 1. Preparation: Weigh accurately about 4.2 g of Sodium Hydroxide and transfer to a 1000ml volumetric flask. Dissolve in sufficient purified water and make up to the mark with purified water. OR As per requirement (consumption history) prepare suitable amount of volumetric solution accordingly. 2. Standardization: Weigh accurately … Read more
Preparation and standardization of 1 M Sodium Hydroxide solution 1. Preparation: Weigh accurately about 42g of Sodium Hydroxide and transfer to a 1000ml volumetric flask. Dissolve in sufficient purified water and make up to the mark with purified water. OR As per requirement (consumption history) prepare suitable amount of volumetric solution accordingly. 2. Standardization: … Read more
Preparation and standardization of 0.1M Perchloric acid solution 1. Preparation: Mix 8.5ml of Perchloric acid with 500ml of anhydrous glacial acetic acid & 25ml of acetic anhydride, cool and add anhydrous glacial acetic acid to produce 1000ml, allow the prepared solution to stand for one day for the excess acetic anhydride to be combined … Read more