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 ...

1.0 OBJECTIVE To ensure that Beximco products are manufactured by the contractor using facilities and operations that conforms to cGMP requirements. 2.0 SCOPE The SOP is applicable for all products of (Company Name) manufactured & packed in a third party contract manufacturer. 3.0 RESPONSIBILITY 3.1 ...

1.0 OBJECTIVE To ensure that all batches of product manufactured at third party contract manufacturer undergo a formal agreement and evaluation of suitability for use prior to release to the market. 2.0 SCOPE The SOP is applicable for contract manufacture and release the product batches manufactured ...

1.0 OBJECTIVE To provide guidelines for preparation, approval & maintenance of new artwork or for changing the existing one, incorporating necessary requirements of Local Drugs Authority or any other regulatory authority, pharmacopoeia or marketing requirements. 2.0 SCOPE This procedure is applicable ...

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 ...

1.0 OBJECTIVE To set up a guideline for the operation, calibration and cleaning of Water Bath (Model:1004) 2.0 SCOPE This SOP is applicable for operation, calibration and cleaning of Water bath (Model: 1004) installed in IPQA Room of OSD facility under Quality Assurance Department of (Company Name). ...

1.0 OBJECTIVE To describe the procedure for assigning unique identification product codes for finished goods and common granules. 2.0 SCOPE This code numbering system is applicable for the entire range of products manufactured at (Company Name). 3.0 RESPONSIBILITY 3.1 Head of concerned departments ...

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 ...

1.0 OBJECTIVE To provide guidelines to record, check, evaluate and summarize the incidence. 2.0 SCOPE This procedure is applicable for handling of incidence of all the systems including manufacturing and control of the products in (Company Name). 3.0 RESPONSIBILITY 3.1 Operator / supervisor shall ...