SOP for Deviation Handling

1. OBJECTIVE • To describe the procedure for handling of deviations. • To lay down the investigation and control procedure for deviation, which can affect the quality of the product, to enable a suitable and prompt action. 2. SCOPE • This SOP is applicable for any deviation in an established process ...

Data Integrity SOP

1.0 PURPOSE: To define a procedure for control of data integrity issues at manufacturing location. 2.0 SCOPE : 2.1 This procedure applies to all the employees working in all the departments and applicable to all GMP documents throughout its lifecycle, of …………….. 3.0 REFERENCE(S) & ATTACHMENTS 3.1 ...

SOP for Handling of Change Control

1. OBJECTIVE 1.1. Change control is a quality tool and a management to maintain and keep the records of all changes as a history. Changes can be related to facility, documentation, system, equipment, instrument, procedure, layouts and products etc. 1.2. To lay down a procedure to describe the handling ...

SOP for Data Integrity

1. Objective 1.1. To lay down a procedure for data integrity as part of quality management system. 1.2. To establish guidelines and procedures to ensure data integrity in regulatory activities. 1.3. To prevent unauthorized access, loss, alteration, or falsification of data throughout the regulatory processes, ...

Vendor Audit

1.0 OBJECTIVE To provide a procedure to evaluate a potential new source or to monitor ongoing quality on a routine basis for existing vendors. 2.0 SCOPE This SOP shall be applicable to all vendors manufacturing raw & packaging materials supply to the BPL. 3.0 ASSOCIATED DOCUMENTS Not applicable. 4.0 ...

SOP for Analytical Method Transfer

1.0 Objective To provide guidelines for the transfer of analytical methods for testing of raw materials and finished products to site laboratories where the routine testing shall be carried out including the training of the concerned analyst and proper documentation. 2.0 Scope This procedure is applicable ...

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 ...

SOP for Product Quality Review (PQR)

OBJECTIVE The objective of carrying out Product Quality Review (PQR) is to establish that the product is manufactured as per approved procedures and the trends of results of critical quality attributes are well within acceptable limits. PQR will also address the review of raw and primary packaging materials ...

Facility Qualification

To lay down the procedure for facility qualification Responsibility: > Engineering Manager or his/her designee will be responsible for initiating facility qualification. > Validation manager will be responsible for checking sufficiency in protocols and reports and requirement of facility qualification ...

Crimping Strength test for MDI Products

Objective: To set up a procedures for crimping strength test for all semi-finished products. Scope: This procedure is applicable for semi-finished products manufactured at MDI unit, (Company Name). Responsibility: 1. IPQA Officer shall be responsible for sampling and testing of semi-finished products ...
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