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
1.0 PURPOSE: To describe the procedure for cleaning of equipments and instruments in Microbiology Laboratory. 2.0 SCOPE: This procedure is applicable to cleaning of equipments and instruments like Autoclave, incubators, hot air oven and refrigerator
1.0 PURPOSE: To define the gram staining procedure to identify the purity of culture by checking the Gram characteristics and to differentiate unknown colony forming units found during microbiological testing. 2.0 SCOPE: This Gram staining
1.0 PURPOSE: To lay down the procedure for cleaning of RO membrane. 2.0 SCOPE: This procedure for cleaning of RO membrane is applicable to RO system at (Company name). 3.0 DEFINITION: Nil 4.0 RESPONSIBILITY: 4.1
1.0 PURPOSE: To lay down a procedure for passivation of purified water distribution system. 2.0 SCOPE: This procedure for passivation of purified water distribution system is applicable to Purified water distribution system at (Company name).
1.0 PURPOSE: To define the operating procedure of chilled water system. 2.0 SCOPE: The SOP for Operating Procedure of Chilled Water System is applicable to chilled water system at (Company name). 3.0 DEFINITION: Chiller Water
Principle: The limit test for Lead (Pb) relies on a reaction between lead impurities and Diphenylthiocarbazone (Dithizone) in a chloroform solution under alkaline conditions. This reaction forms a Lead-dithizone complex, which exhibits a red coloration. In
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
Principle: The limit test for sulphate based on the interaction between soluble sulphate and barium chloride in the presence of dilute hydrochloric acid. This reaction produces barium sulphate, which manifests as solid particles (turbidity) within
Principle: The limit test for iron is based on the formation of the purple color through interaction of iron with thioglycolic acid within a solution buffered with ammonium citrate. This resultant produced is then compared
Limit test definition Limit: Threshold indicating presence or absence of substance in sample.Test: Qualitative or semi-quantitative analysis determining substance presence.Impurities: Undesirable substances present in material or chemical compound. “Limit test is defined as quantitative or
Definition of limit test: Limit test are quantitative or semi-quantitative tests designed to identify and control small quantities of impurity, which are like to be present in the substance. The quantity of any one impurity
The Significance of Limit Testing: Limit testing involves determining the maximum allowable concentration of a substance, beyond which it poses a risk to human health or the environment. For arsenic, establishing these limits is crucial
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 Operation, Cleaning and Calibration of Ultra Violet Cabinet. 2.0 SCOPE: This SOP covers the procedure for Operation, Cleaning and Calibration of Ultra Violet Cabinet (Make- Aarkey Labtronix
1.0 PURPOSE: To define the procedure for cleaning of laboratory glassware used for analytical purpose, to avoid any cross contamination which results in erratic values. 2.0 SCOPE: The procedure for cleaning of laboratory glassware is
1.0 PURPOSE: To lay down the procedure for cleaning and sanitization of waste bins. 2.0 SCOPE: This procedure is applicable for cleaning and sanitization of waste bins in (Company name). 3.0 DEFINITIONS: Nil 4.0 RESPONSIBILITY:
1.0 PURPOSE: To define the procedure for total viable spore count determination of Biological indicator. 2.0 SCOPE: This procedure for total viable spore count determination of biological indicators is applicable to Quality Control Department, at
Quality Management System Definition: A Quality Management System (QMS) is a set of procedures, policies, plans, resources, processes, practices, specification of responsibilities and authority of an organization designed to achieve product and service quality levels,
1.0 PURPOSE: To define the procedure for operation and cleaning of cooling cabinet. 2.0 SCOPE: This procedure for operation and cleaning of cooling cabinet is applicable to warehouse department (Company name). 3.0 REFERENCE: Nil 4.0 DEFINITION: Cooling
1.0 PURPOSE: To define the procedure for handling and storage of raw and packaging materials. 2.0 SCOPE: This procedure for handling and storage of raw and packaging materials is applicable to warehouse department at (Company
1.0 PURPOSE: To define the procedure for operation and cleaning of vacuum cleaner. 2.0 SCOPE: This procedure for operation and cleaning of vacuum cleaner is applicable to warehouse/production department at (Company name). 3.0 REFERENCE: Nil
1.0 PURPOSE: To define the procedure for disposal of waste materials in warehouse. 2.0 SCOPE: This procedure for disposal of waste materials in warehouse is applicable to warehouse department at (Company name). 3.0 REFERENCE: NIL
1.0 PURPOSE: To define the procedure for safety and precautions in warehouse. 2.0 SCOPE: This procedure for safety and precautions in warehouse is applicable to warehouse department of (Company name). 3.0 REFERENCE: NIL 4.0 DEFINITION:
1.0 PURPOSE: To lay down the Procedure for Hydrostatic test for pipe lines. 2.0 SCOPE: This procedure applies for Hydrostatic test for all the MS, SS, PP and GI pipe lines (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To lay down the Procedure for Calibration of Dosing Pumps. 2.0 SCOPE: Procedure for Calibration of Dosing Pumps is applicable to all the Dosing Pumps related to the water plant at (Company name).
1.0 PURPOSE: To lay down the procedure for operation and cleaning of portable de-humidifier. 2.0 SCOPE: This procedure for operation and cleaning of portable de-humidifier is applicable at (Company name). 3.0 DEFINITIONS: De-humidification: Removing of
1.0 PURPOSE: To lay down the procedure for Operation and Calibration of Micropipettes. 2.0 SCOPE: This SOP is applicable for Operation and Calibration of Micropipettes used in Quality Control Department at (Company name). 3.0 REFERENCE:
1.0 PURPOSE: To lay down the Operation and Calibration procedure of Bursting Strength Test Apparatus. 2.0 SCOPE: SOP for Operation and Calibration of Bursting Strength Test Apparatus is applicable in Quality Control Department at (Company
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: To lay down the procedure for operation and verification of Eye Washer and safety shower. 2.0 SCOPE: This procedure is applicable for the Operation of Eye Washer and safety shower in Quality Control
1.0 PURPOSE: To lay down the procedure for polishing of punches and dies. 2.0 SCOPE: SOP for polishing of punches and dies is applicable at production department of (Company name). 3.0 DEFINITIONS: NIL 4.0 RESPONSIBILITY:
1.0 PURPOSE: To lay down the procedure for inspection of uncoated tablets. 2.0 SCOPE: SOP for inspection of uncoated tablets is applicable at production department of (Company name). 3.0 DEFINITIONS: NIL 4.0 RESPONSIBILITY: 4.1 Production
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 lay down the procedure for usage and control of machine lubricants. 2.0 SCOPE: This procedure is applicable for usage and control of machine lubricant’s in OSD block at (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To lay down the procedure for operation and cleaning of LAF’s and RLAF’s. 2.0 SCOPE: SOP for operation and cleaning of LAF and RLAF is applicable both in injectable and OSD block at
1.0 PURPOSE: To lay down the procedure for operation and cleaning of dynamic pass box. 2.0 SCOPE: SOP for operation and cleaning of dynamic pass box is applicable for operation and cleaning of dynamic pass
1.0 PURPOSE: To lay down the procedure for manual defoiling of blisters and bottles. 2.0 SCOPE: The SOP for manual defoiling of blisters and bottles is applicable for manual defoiling of blister and bottles at
1.0 PURPOSE: To define the procedure for Re-packing of tablets and Capsules. 2.0 SCOPE: Procedure for Re-Packing is applicable for all products packed in Production Department of at (Company name). 3.0 DEFINITION: Not applicable. 4.0
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