admin 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
sop for preparation 0.05M edetate disodium 1. Preparation: Weigh accurately about 18.6 g 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: Method 1: Weigh … Read more
sop for preparation 0.1M silver nitrate 1. Preparation: Weigh accurately about 17.0g of silver nitrate 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 about … Read more
sop for vendor selection and Evaluation 1.0 OBJECTIVE 1.1 The main objective of a pharmaceutical plant is to produce finished products for the patients’ use from a combination of materials. The quality, timely delivery and cost of incoming materials are the critical aspects that will affect the final product. So special attention is to be … Read more
sop for BET (Bacterial Endotoxin) test in Microbiology 1.0 OBJECTIVE 1.1 To down the bacterial endotoxin in WFI & finished pharmaceutical product. 2.0 SCOPE 2.1 This procedure applicable for Bacterial Endotoxin Test in Microbiology Laboratory . 3.0 RESPONSIBILITY 3.1 Microbiologist QC 4.0 ACCOUNTABILITY 4.1 QC Manager 5.0 PROCEDURE 5.1 MATERIALS REQUIRED: 5.1.1 LAL Reagent … Read more
sop for Format issuance and control 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for distribution & control of different types of formats to different departments by QA. 2.0 SCOPE 2.1 This SOP is applicable for distribution & control of different types of formats to different departments by … Read more