SOP for Quality Management System review

OBJECTIVE To review the Quality Management System implementation status and to plan for resolving any outstanding issue and for closing the gaps. SCOPE This SOP is applicable for holding Quality Management Review meeting system in (Company Name). RESPONSIBILITY 1. Team members of concerned departments ...

Quality Assurance Functions

a. Quality Assurance Department ensures the quality of all batches produced at every stage of manufacturing/processing of drug products. b. This is achieved by performing monitoring functions in accordance with the prescribed QA system for the following areas: =>> Warehousing of incoming material, containers ...

Failure Investigation

OBJECTIVE : To provide the guidelines for investigation, root cause analysis, their evaluation and corrective actions to prevent recurrence. SCOPE : This procedure is applicable for a common failure investigation root & cause analysis process for the failure occurs in set product, process and quality ...

SOP for Process Optimization

1.0 OBJECTIVE To lay down a procedure for execution of process optimization activity. 2.0 SCOPE 2.1 This procedure is applicable to all the products intended to be manufactured in (Company Name). 3.0 RESPONSIBILITY 3.1 QA/Validation shall be responsible for preparation of Process Optimization ...

SOP for Market Complaints

1.0 OBJECTIVE To describe a procedure for handling market complaints and take appropriate corrective action to address the complaint as well as to prevent a recurrence. 2.0 SCOPE This procedure is applicable to all types of market complaints that are related to quality, packing, and/or shortage of ...

Quality assurance system

1 Principle. “Quality assurance” is a broad concept that covers all factors that individually or collectively affect the quality of a product. The totality of measures taken to ensure that pharmaceutical product ucts are of the required quality for their intended use. Quality assurance therefore ...

SOP for Operation of Friability tester

1.0 OBJECTIVE To set up a procedure for the operation and cleaning of Tablet Friability Tester (Model: TA/TAR). 2.0 SCOPE This SOP is applicable for the operation and cleaning of Tablet Friability Tester (Model: TA/TAR) at Quality Assurance Department of (Compnay Name). 3.0 RESPONSIBILITY 3.1 Operating ...

SOP for Facility Qualification

1.0 OBJECTIVE To lay down the procedure for facility qualification. 2.0 SCOPE All manufacturing, packaging, storage and other relevant area in (Compnay Name). 3.0 RESPONSIBILITY 3.1 Engineering Manager or his/her designee will be responsible for initiating facility qualification. 3.2 Validation manager ...

SOP for Certification of QA Personnel

1.0 OBJECTIVE To confirm that the personnel performing the tests in IPQA and other documentations in Quality Assurance are adequately trained to produce reliable and accurate results within the specified parameters. 2.0 SCOPE This procedure is applicable to IPQA officers to assure that the analysts ...

SOP for Batch numbering system for Milled material

Objective To describe the procedure of batch numbering system for material milling in production facility of (Company Name). Scope This procedure is applicable for the numbering of the material milling in the manufacturing facility of (Company Name). Responsibility =>> Production planning personnel. ...
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