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
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
storage retention and destruction policy 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for storage, retention and destruction of master/filled documents. 2.0 SCOPE 2.1 This SOP is applicable for all the master/filled documents of all departments 3.0 RESPONSIBILITY 3.1 Asst. Officer or above –Quality Assurance – Prepare the SOP and … 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