GAMMA BENZENE HEXACHLORIDE LOTION
GAMMA BENZENE HEXACHLORIDE LOTION PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: …
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MFR of Antacid
MFR of Antacid PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP. The Production…
Betamethasone and Salicylic Acid Ointments
Betamethasone and Salicylic Acid Ointments PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Manufacturing Chemist to follow and adhere to this SOP….
Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets
Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to…
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Acetaminophen, Pseudoephedrine Hydrochloride & Cetirizine Dihydrochloride Tablets
Acetaminophen, Pseudoephedrine Hydrochloride & Cetirizine Dihydrochloride Tablets PURPOSE: This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form. SCOPE: This procedure is performed and is applied during the manufacturing of dosage form. RESPONSIBILITY / ACCOUNTABILITY: It is the responsibility of Assistant Manufacturing Chemist to follow and adhere to…
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Reporting, Investigating and Disposition of Incidents in Quality Assurance Department
Reporting, Investigating and Disposition of Incidents in Quality Assurance Department OBJECTIVE : To lay down a procedure for reporting, investigating and disposition of incidents in Quality Assurance Department. RESPONSIBILITY : Officer-QA to raise Incident Report to allot number & due date to the Incident Report. Officer-QA & Head-QA or his designee to investigate and take necessary…
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Storage, Retrieval, Control and Retention of all completed Documents
Storage, Retrieval, Control and Retention of all completed Documents OBJECTIVE : To outline a procedure for the storage, retrieval, control and retention of all completed documents, related to various functional areas to ensure security and traceability of completed records. RESPONSIBILITY : Concerned HOD or his designee to arrange for submitting respective completed documents related to their functional area….
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Process Validation Programme
Process Validation Programme OBJECTIVE : To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes. RESPONSIBILITY : Research Development to prepare and execute the validation protocol and to prepare a final report on Process Validation. Production to execute the…
Preparation, Approval, Issue and Control of Art works for labeling of drug products
Preparation, Approval, Issue and Control of Artworks for labeling of drug products OBJECTIVE : To lay down the Procedure for Preparation, Approval, Issue and Control of artworks for labeling of drug products intended for commercial use. RESPONSIBILITY : R&D(Packaging Development) to prepare the Artwork, positives or soft copy, and procure shade cards & specimens from the printers….
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INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH
INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH TABLE OF CONTENT Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Critical Instrument Calibration Verification Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion…
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