SITE MASTER FILE Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections. The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out … Read more
QUALITY MANUAL QUALITY MANUAL describes one comprehensive model for an effective pharmaceutical quality system that is based on the quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements serves as the Validation Road map, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that … Read more
DQ (DESIGN QUALIFICATION) DOCUMENT FOR AHU- 4000 CFM / 150 mm wg – SP To prepare detailed specifications (Design data) for HVAC System and its major components, to Ensure that the User Requirement Specifications, as described in RDS are achieved. To design the system in conjunction with the design data in order to provide basis for … Read more
ENVIRONMENTAL FAILURE (STEPS TO BE TAKEN IN CASE) PURPOSE: To lay down a procedure for steps to be taken in case of environmental failure. SCOPE: This SOP is applicable for steps to be taken in case of environmental failure in Dry Powder Injection section. RESPONSIBILITY: Preparation of SOPs: Officer/ Executive of Production Departments Checking and … Read more
SOP ON CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) PURPOSE: To lay down the standard operating procedure for Corrective Action and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. SCOPE: This SOP is applicable … Read more
SOP OF PRODUCT RECALL PURPOSE: This procedure covers transmission of information by means of a Rapid Alert between the different parties related to the recall of medicinal products, which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health. The procedure may be used also for transmission of … Read more
(DQ)DESIGN QUALIFICATION FOR PURE STEAM GENERATION SYSTEM DQ- The Author signature indicates that this document has been prepared in accordance with existing cGMP standards and adequately reflects the tasks and deliverables necessary for qualification of the equipment. REVIEWED BY: The reviewer’s signature indicates that, this document has been reviewed, and it accurately and completely reflects the … Read more
Design Qualification (DQ) Protocol Form Fill Seal Blow-Fill-Seal (BFS) technology is a manufacturing technique used to produce small, (0.1mL) and large volume, (500mL +) liquid-filled containers. The basic concept of BFS is that a container is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. … Read more
SOP Preparation of User Requirement Specification (URS) Objective: To lay down a procedure for preparation, review and approval of user requirement specification. Scope: This procedure outlines the requirements, which shall be followed when creating a User Requirement Specification (URS), which is referred to as system or equipment design documentation. This procedure applies to all systems or … Read more
URS (USER REQUIREMENT SPECIFICATION) PROTOCOL FOR DYNAMIC PASS BOX This is a specific document prepared for the sterile facility. Hence, this document before being effective shall be approved and authorized by Unit Head and accepted by Vendor/Supplier. List of Content Front Page Index Approval Objective Responsibility Equipment description & Identification User Requirement Complementary aspects Safety … Read more