sop for quality risk assessment 1.0 OBJECTIVE 1.1 To provide a guideline for conducting risk assessment. 1.2 Provide the systematic approach to achieve the quality standards by assessing, controlling, communicating and reviewing risks related to product quality, safety and efficacy, System, Process, Facility, Document and Environment. 2.0 SCOPE 2.1 This procedure is applicable to … Read more
sop for handling of incidents 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for handling of incidents. 2.0 SCOPE 2.1 This SOP is applicable for handling of incident at production area 3.0 RESPONSIBILITY 3.1 Asst. Officer or Above –Quality Assurance – Prepare the SOP and follow-up the SOP accordingly. … Read more
sop for handling of deviations 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for handling of all deviations observed at any stage either during receipt and handling of RM /PM or during it’s storage, during processing, testing, manufacturing and packaging operations involved during manufacture of pharmaceutical finished products. 2.0 SCOPE … Read more
sop for change control policy 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for proposed changing, evaluation of change, approval of change in the existing document / system / facility / process etc. related to manufacturing of a product. 2.0 SCOPE 2.1 This SOP is applicable to changes in following … Read more
sop for preparation and standardization 0.1M sodium thiosulphate 1. Preparation: Weigh accurately about 25g of Sodium Thiosulphate and 0.2g of sodium carbonate 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 … Read more
sop for training program 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for providing training to new and existing employees / workers of the organization. 2.0 SCOPE 2.1 This procedure is applicable for providing training to the new and existing employees / workers 3.0 RESPONSIBILITY 3.1 Asst. Officer or above–Quality … Read more
sop for storage and destruction of Batch Manufacturing Records 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for issuance, receipt, reviewed, storage and destruction of Batch Manufacturing/Packing Records. 2.0 SCOPE 2.1 This SOP is applicable for issuance, receipt, reviewed, storage and destruction of BMRs/BPRs of products being manufactured 3.0 RESPONSIBILITY … Read more
sop for good documentation practices 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for enable the company to demonstrate conformance to both internal and external standards with documentation. 2.0 SCOPE 2.1 This SOP is applicable for doing good documentation practices related with records certifying follows up of standard practices, … Read more
sop for issue and retrieval of filled documents 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for issuance and retrieval of filled documents. 2.0 SCOPE 2.1 This SOP is applicable for issuance and retrieval of filled documents 3.0 RESPONSIBILITY 3.1 Asst. Officer or above QA / Executive – Concerned Department … Read more
sop for document control system 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for document controlling system. 2.0 SCOPE 2.1 This SOP is applicable for document control system 3.0 RESPONSIBILITY 3.1 Asst. Officer or above – Quality assurance-Prepare the SOP and follow-up the SOP accordingly 3.2 Asst. manager –Quality assurance … Read more