1.0 PURPOSE: To lay down procedure for conducting Acceptable Quality Level (AQL) for products at various stages; including Compression, Coating and Capsule filling. 2.0 SCOPE: This procedure conducting Acceptable Quality Level (AQL) is applicable to

1.0 PURPOSE: To define comprehensive approach to the validation of cleaning procedure for equipment area used in manufacturing process. 2.0 SCOPE: This SOP for cleaning validation in pharma is applicable to cleaning validation at (Company

1.0 PURPOSE: The purpose of the procedure for change control programme in pharma is to have documented procedure for initiation, evaluation, approval and implementation of change control. 2.0 SCOPE: 2.1 This procedure for change control

1.0 PURPOSE: To define the procedure for handling of temporary change control (Planned deviation) during operations. 2.0 SCOPE: This procedure for handling of temporary change control is applicable to all departments in (Company name). The

1.0 PURPOSE: To lay down the procedure for reworking or reprocessing of pharmaceutical product. 2.0 SCOPE: This procedure for reworking or reprocessing of pharmaceutical product is applicable at Pharmaceutical Manufacturing Facility of (Company name). 3.0

1.0 PURPOSE: To describe the responsibilities of quality units. 2.0 SCOPE: This SOP describes the functions and responsibilities of quality units at (Company name). 3.0 DEFINITIONS: Nil 4.0 RESPONSIBILITY: 4.1 All personnel in Quality Unit

1.0 PURPOSE: To lay down the procedure for the Preparation, Review and Approval of Validation Master Plan. 2.0 SCOPE: This procedure applicable for preparation of Validation Master Plan at Pharmaceutical Manufacturing Facilities of (Company name).

1.0 PURPOSE: To provide a procedure for conducting the Management Review Meeting (MRM). 2.0 SCOPE: This procedure is applicable to management review meeting (MRM). The meeting is conducted for assessing the quality management system and