sop for handling of out of specification results OOS 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for handling of out of specification results (OOS) generated during the testing of Raw material, packing material, In-process samples, finished product samples and stability samples. 2.0 SCOPE 2.1 This SOP is applicable … Read more
sop for control sample management 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for the collection, storage, periodical inspection, and destruction of control samples & to maintain the relevant Records. 2.0 SCOPE 2.1 This SOP is applicable for collection, storage, periodical inspection, and destruction of control samples & to … Read more
sop for prevention of cross contamination 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for checks follows for prevention of cross contamination. 2.0 SCOPE 2.1 This SOP is applicable for various system controls to prevent cross contamination in manufacturing and packing area in factory premises 3.0 RESPONSIBILITY 3.1 Asst. … Read more
sop for entry of authorized person 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for entry of authorized person. 2.0 SCOPE 2.1 This SOP is applicable for entry of authorized person in concerned department 3.0 RESPONSIBILITY 3.1 Asst. Officer or above-Quality Assurance – Prepare the SOP and follow-up the … Read more
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 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