1.0 OBJECTIVE: The aim of this cleaning validation protocol is to provide documented evidence that the cleaning procedure designated for each equipment used & unused for products manufactured in manufacturing area are capable of removing

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 is applicable to cleaning validation at (Company name). 3.0

1.0 PURPOSE: The purpose of this SOP is to provide procedure for temperature and RH mapping of controlled area and equipment’s. 2.0 SCOPE: This procedure for temperature and RH mapping is applicable to all controlled

1.0 PURPOSE: To lay down the procedure for conduct the mock recall. 2.0 SCOPE: This SOP is applicable to conduct the mock recall of finished product manufactured at (Company name). The scope does not include

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

Failure Mode Effects Analysis (FMEA): Risk management tools are primary tools that can be used in quality Risk Management. FMEA (Failure Mode Effects Analysis) is a powerful tool used in pharmaceutical industry which breaks down

1.0 PURPOSE: To provide procedure for sampling of In-process and finished products of oral solid dosages and Injectables. 2.0 SCOPE: This procedure for sampling of In-process and finished products is applicable for sampling of In-process

1.0 PURPOSE: 1.1 To lay down a procedure for identification and evaluation of risk involved in quality management. 1.2 The objective of this document is to offer site a systematic approach to quality risk management.

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 lay down the procedure for the process validation of pharmaceutical products. 2.0 SCOPE: This procedure is applicable for the process validation of products to ensure that a specific process will consistently produce

1.0 PURPOSE: The purpose of the procedure is to have documented procedure for initiation, evaluation, approval and implementation of change control. 2.0 SCOPE: 2.1 This sop for change control management is applicable to (Company name).2.2

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

Safety and quality of drug product are main concern during a power failure in the pharmaceutical industry. Backup power systems, like generators and uninterruptible power supplies (UPS) should be available and maintained to keep critical

1.0 PURPOSE: To define the procedure for handling of returned drug products and to define the methodology for drug product salvaging. 2.0 SCOPE: The SOP for handling of returned drug products is applicable to handling

1.0 PURPOSE: To define the procedure of Job Responsibilities of Quality Assurance at Unit level. 2.0 SCOPE: This procedure is applicable to Quality Assurance department at (Company name). 3.0 DEFINITION: An order to effectively manage

Data integrity stands as a paramount concern for regulators globally. It is due to poor practices develop by the industry. Collection of various types of information and results collectively called as data. This data are

1.0 PURPOSE: To lay down a procedure for Preparation, Review, Approval, Control and Revision of Site Master File. 2.0 SCOPE: This procedure is applicable for Preparation, Review, Approval, Control and Revision of Site Master File

1.0 PURPOSE: SOP for handling of deviation is to establish a system for identification, recording, evaluation and approval of any Deviations from the standard procedure. 2.0 SCOPE: This SOP for handling of deviation is applicable

1.0 PURPOSE: To describe the procedure for administration of Corrective and Preventive action (CAPA) , including tracking and reporting of the status of CAPA. 2.0 SCOPE: The SOP for corrective and preventive action (CAPA )

1.0 PURPOSE: To lay down a procedure for Hold Time Study of pharmaceutical products for various stages of manufacturing process. 2.0 SCOPE: The SOP for Hold Time Study of Pharmaceutical Products is applicable to the

1.0 PURPOSE: The SOP for self-inspection (Internal Audit) provides the procedure for self-inspection (Internal Audit) to verify compliance with cGMP. 2.0 SCOPE: This procedure applies to self-inspection (Internal Quality Audit) conducted by suitably experienced and trained personnel

1.0 PURPOSE: To lay down a procedure for introduction of any new product into the manufacturing facility with adequate assessment, in line with established system / procedure. 2.0 SCOPE: SOP for introduction of new product

1.0 PURPOSE: The purpose of this procedure is to provide guidelines for preparation, approval, issue of protocols and preparation and approval of reports. 2.0 SCOPE: The SOP for preparation of protocol and report is applicable to

1.0 PURPOSE: To lay down the procedure for cleaning of Sampling Tools. 2.0 SCOPE: This SOP for cleaning of sampling tools and accessories is applicable to all sampling tools (Rod, dies, scoops, spatula, etc.) used

1.0 PURPOSE:To lay down a procedure for preparation, review and approval of facility qualification document. 2.0 SCOPE:This procedure is applicable for preparation, review and approval of facility qualification at (Company name). 3.0 DEFINITIONS:Nil 4.0 RESPONSIBILITY:4.1