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 a procedure for Operation, cleaning and calibration of Scott Volumeter (Density Apparatus). 2.0 SCOPE: This procedure covers the Operation, cleaning and calibration of Scott Volumeter (Density Apparatus), which is used
1.0 PURPOSE: To lay down a procedure for operation and cleaning of Visual inspection board. 2.0 SCOPE: This procedure covers the operation and cleaning of Visual inspection board which is used in Quality Control department
1.0 PURPOSE: To lay down a procedure for operation and cleaning of Biosafety cabinet used in microbiology Laboratory. 2.0 SCOPE: This procedure for operation and cleaning of Biosafety cabinet is applicable to Biosafety cabinet used
1.0 PURPOSE: To lay down a procedure for operation and cleaning of fogger used in microbiology Laboratory. 2.0 SCOPE: This procedure applicable for operation and cleaning of fogger used in microbiology laboratory at (Company name).
1.0 PURPOSE: To establish a standardized procedure for sampling of compressed gasses used in manufacturing process to ensure their quality and compliance with specified requirements. 2.0 SCOPE: This procedure for sampling of compressed gasses used
1.0 PURPOSE: To provide the procedure for operation and cleaning of microscope used in Microbiology laboratory department. 2.0 SCOPE: This procedure for operation and cleaning microscope is applicable at (Company name). 3.0 DEFINITIONS: Nil. 4.0
1.0 PURPOSE: To lay down a procedure for Operation and cleaning of Centrifuge apparatus. 2.0 SCOPE: This procedure covers Operation and cleaning of Centrifuge apparatus which is used in Quality Control department at (Company name).
1.0 PURPOSE: To lay down the procedure for operation, cleaning and calibration of pH meter used in Quality control department. 2.0 SCOPE: This procedure applicable for operation, cleaning and calibration of pH, which is used
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 provide a procedure to establish alert and action limits for data obtained in environmental monitoring. 2.0 SCOPE: This procedure is applicable to establish alert and action limits for data obtained in environmental
1.0 PURPOSE: To lay down a procedure for monitoring the Quality of Raw Water based on EPA guidelines. 2.0 SCOPE: This procedure for monitoring the Quality of Raw Water based on EPA guidelines is applicable
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 dumping challenge test for RO, EDI, Purified water and WFI System. 2.0 SCOPE: This procedure applies for dumping challenge test for RO, EDI, Purified Water and WFI
1.0 PURPOSE: To lay down the procedure for chemical sanitization of potable water storage and distribution system. 2.0 SCOPE: This procedure applies for chemical sanitization of potable water storage and distribution system at (Company name).
1.0 PURPOSE: To lay down the Procedure for Air flow Pattern visual test. 2.0 SCOPE: This procedure applies for Air flow Pattern visual test at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel
1.0 PURPOSE: To lay down the Procedure for measurement of Air Velocity and air changes per hour. 2.0 SCOPE: This procedure applies for measurement of Air Velocity and air changes per hour at (Company name).
1.0 PURPOSE: To lay down the Procedure for Integrity test of HEPA Filters. 2.0 SCOPE: This procedure applies for Integrity test of HEPA Filters at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel
1.0 PURPOSE: To lay down the Procedure for Differential pressure measurement across HEPA Filter. 2.0 SCOPE: This procedure for Differential pressure measurement across HEPA Filter is applicable at (Company mane). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY:
1.0 PURPOSE: To lay down the Procedure for HVAC Duct cleaning and leak Test. 2.0 SCOPE: This procedure applies for HVAC Duct cleaning and leak Test at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1
1.0 PURPOSE: To lay down the procedure for identification and control of materials due for retest and expiry. 2.0 SCOPE: This procedure for identification and control of materials due for retest and expiry is applicable
1.0 PURPOSE: To lay down the procedure for code to code transfer of raw / packaging materials. 2.0 SCOPE: This procedure for code to code transfer of raw / packaging materials is applicable in Warehouse
1.0 PURPOSE: To define the procedure for operation and cleaning of dispensing booth and accessories. 2.0 SCOPE: This procedure for operation and cleaning of dispensing booth and accessories is applicable to warehouse department at (Company
1.0 PURPOSE: To lay down the procedure for dispensing raw materials in Warehouse department. 2.0 SCOPE: This procedure for dispensing of raw materials is applicable in warehouse department (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY:
1.0 PURPOSE: To lay down the procedure for Dispensing of Packaging Materials to Production and Packing Department. 2.0 SCOPE: This procedure for Dispensing of Packaging Materials is applicable to warehouse Department (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To lay down the Procedure for electrical safety guidelines while working on equipment’s connected by electrical power supply to avoid electrical accident and ensure personal safety. 2.0 SCOPE: This procedure for electrical safety
1.0 PURPOSE: To provide methods for microbiological analysis of primary packaging material to determining the bio burden (i.e. total bacterial and fungal count) of primary packaging material. 2.0 SCOPE: This procedure for microbiological analysis of
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 lay down the procedure for operation and cleaning of static passbox. 2.0 SCOPE: This procedure is applicable for operation and cleaning of static passbox in Warehouse and Production department at (Company name).
1.0 PURPOSE: To lay down a procedure for testing and release of in-Process, semi-finished and finished products samples in Quality Control Laboratory. 2.0 SCOPE: This procedure is applicable for testing and release of in-process, semi-finished
1.0 PURPOSE: To lay down the procedure for operation and cleaning of slurry preparation vessel. 2.0 SCOPE: This procedure is applicable for operation and cleaning of slurry preparation vessel at (Company name). 3.0 DEFINITIONS: Nil.
1.0 PURPOSE: To provide a procedure for cleaning and sterilization / depyrogenation of glassware / accessories. 2.0 SCOPE: This SOP is applicable for cleaning and sterilization / depyrogenation of glassware / accessories at Microbiology laboratory
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: This procedure elaborates the methods of labeling, incubation and observation of microbial media filled Petri plate / glassware that are used in microbiological analysis. 2.0 SCOPE: This SOP is applicable for labeling, incubation
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: 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
1.0 PURPOSE: To lay down a procedure for the preparation of 10-100 cfu/ml culture suspension. 2.0 SCOPE: This procedure is applicable to preparation of 10-100 cfu/ml culture suspension prepared in Quality Control Department at (Company
1.0 PURPOSE: To lay down the procedure for destruction of sample after analysis. 2.0 SCOPE: This procedure for destruction of sample after analysis is applicable to all left over samples after analysis in Quality Control
1.0 PURPOSE: To define the procedure for cleaning of glassware for microbiological testing purposes to avoid any cross contamination. 2.0 SCOPE: This procedure is applicable for cleaning of glassware for microbiological testing used in Quality
1.0 PURPOSE: To lay down a procedure for retain the specimen proof with batch packing record. 2.0 SCOPE: This procedure is applicable for retain the specimen proof with batch packing record in production department at
1.0 PURPOSE: To lay down a procedure for action plan in case of in process check and challenge test failure. 2.0 SCOPE: This procedure is applicable for action plan to be taken in case of
1.0 PURPOSE: To define the procedure for handling of materials in material staging room. 2.0 SCOPE: This procedure is applicable for handling of materials in material staging room at Production department of (Company name). 3.0
1.0 PURPOSE: To define the procedure for handling of materials in quarantine 2.0 SCOPE: This SOP for handling of materials in quarantine is applicable for Production Department at (Company name). 3.0 RESPONSIBILITY: 3.1 Production personnel
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