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
Tablet compression machines are designed with consideration of the types of dies and punches they will use. The dies and punches and their setup on compression machine is called tablet tablet tooling , it is
1.0 PURPOSE: To lay down the procedure for Operation and Maintenance of Infrared sterilizer. 2.0 SCOPE: This SOP for Operation and Maintenance of Infrared sterilizer is applicable in Microbiology Laboratory, at (Company name). 3.0 DEFINITION:
1.0 PURPOSE: To lay down a procedure for operation, cleaning, maintenance and calibration of Oven. 2.0 SCOPE: This procedure is applicable for the Operation and cleaning, maintenance and calibration of Oven in Quality Control Department
1.0 PURPOSE: To lay down a SOP for handling of alarms for critical equipments. 2.0 SCOPE: This SOP for handling of alarms for critical equipments is applicable in Production department at (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To define the procedure for Handling of Raw Material Spillage. 2.0 SCOPE: This SOP for Handling of Raw Material Spillage is applicable to Warehouse Department at (Company name). 3.0 DEFINITION: Not Applicable. 3.0
1.0 PURPOSE: To lay down the procedure for critical area practices in critical areas. 2.0 SCOPE: This SOP for critical area practices is applicable in critical areas of Injectable area at (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To define the procedure for integrity testing of vent filter by Bubble point test. 2.0 SCOPE: This procedure for integrity testing of vent filter is applicable at (Company name). 3.0 DEFINITION: Not Applicable.
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 lay down the procedure for receipt and issuance of Packing materials for machine trial. 2.0 SCOPE: This procedure for receipt and issuance of Packing materials for machine trial is applicable for receipt
1.0 PURPOSE: To define the procedure for cleaning of water tanks used in purified water generation system. 2.0 SCOPE: This procedure for cleaning of water tanks is applicable to water tanks which are being used
Principle: The limit test for heavy metals relies on the reaction of metallic impurities with hydrogen sulfide in an acidic environment, resulting in the formation of a brownish-colored solution. Metals that react to this test
Definition of Good laboratory practices (GLP): Good Laboratory Practices (GLP): Good Laboratory Practices is a quality system comprises with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, reported
1.0 PURPOSE: To define the procedure for spore staining. 2.0 SCOPE: The procedure for spore staining is applicable to Microbiology department at (Company name). 3.0 DEFINITION: Not Applicable 4.0 RESPONSIBILITY: 4.1 Trainee/officer is responsible to
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