Process Flow-Sheet of QA Person

Process Flow-Sheet of QA Person 

Stage.1: BMR & R. M requisition issue by Quality Assurance (QA).

Stage.2: Indent of R. M. & P.M. Requisitions by Production as per BMR.

Stage.3: Requisition checking & stamping the BMR by Quality Assurance (QA).

Stage.4: Dispensing of Raw & Packing Materials in presence of Production, QA & Store person.

Stage.5:  (After Issuing) Verification of Raw & Packing Materials by Production person.

Stage.6: Equipment & Area Clearance by QA.

Stage 7: Preparation of Bulk in process (Intermediate)

Stage.8 : Centrifuge & Drying.

Stage.9. Milling of oversized granules if required.

Stage.10: Intermediate granules Sampling, Testing and Release by Quality Control (QC).

Stage.11: After Testing and Release of  bulk or in process by Quality Control (QC),

Stage.12: QA in process Checking. bulk Wt variation, etc.

Stage  13  Wet product Drying ,after  Milling and sifter

Stage.14: Line Clearance by QA for Packing Activity.

Stage.15: Overprinting & approval of Primary & Secondary Packing Materials.

Stage.16: Final Packing.

Stage.17: Collecting the retain samples by Q. C.

Stage.18: Finished product Sampling, Testing and Release of Finish Product by Quality Control (QC).

Stage19: Finished Product Transfer slip issued by approved chemist to Bonded Store Room. (BSR) / Finished Goods Store (FGS).

Stage.20: F. P. Inspection & release By Q. A.

Stage.21: Dispatch of F. P.

C. T. D. FORMAT FOR DRUG MASTER FILE

C. T. D. FORMAT FOR DRUG MASTER FILE

INDEX

PART	DATA MODULE	PAGE
2.0	COMMON TECHNICAL DOCUMENT SUMMARY
2.3.S	QUALITY OVERALL SUMMARY
2.3.S.1	GENERAL INFORMATION
2.3.S.2	MANUFACTURE
2.3.S.3	CHARACTERZATION
2.3.S.4	CONTROL OF DRUG SUBSTANCE
2.3.S.5	REFERENCE STANDARD
2.3.S.6	CONTAINER CLOSURE SYSTEM
2.3.S.7	STABILITY
3.0	QUALITY (CHEMICAL AND PHARMACEUTICAL INFORMATION)
3.1	TABLE OF CONTENTS
3.2	BODY OF DATA
3.2.S	DRUG SUBSTANCE
3.2.S.1	GENERAL INFORMATION
3.2.S.1.1	NOMENCLATURE
3.2.S.1.2	STRUCTURE
3.2.S.1.3	GENERAL PROPERTIES
3.2.S.2	MANUFACTURE
3.2.S.2.1	MANUFACTURER
3.2.S.2.2	DESCRIPTION OF MANUFACTURING PROCESS AND PROCESS CONTROL
3.2.S.2.2	FLOW CHART OF MANUFACTURING PROCESS
3.2.S.2.2	SYNTHETIC ROUTE OF MANUFACTURING PROCESS
3.2.S.2.2	MANUFACTURING PROCESS DETAILS
3.2.S.2.3	CONTROL OF RAW MATERIAL
3.2.S.2.4	CONTROL OF CRITICAL STEP AND INTERMEDIATES
3.2.S.2.5	PROCESS VALIDATION
3.2.S.2.6	MANUFACTURING PROCESS DEVELOPMENT
3.2.S.3	CHARACTERISATION
3.2.S.3.1	ELUCIDATION OF STRUCTURE AND OTHER CHARACTRISTICS
3.2.S.3.1.1	ELEMENTAL ANALYSIS
3.2.S.3.1.2	INFRA RED SPECTRUM OF THE DRUG SUBSTANCE
3.2.S.3.1.3	NMR SPECTRUM OF DRUG SUBSTANCE
3.2.S.3.1.4	MASS SPECTRUM OF DRUG SUBSTANCE
3.2.S.3.1.5	UV SPECTRUM OF DRUG SUBSTANCE
3.2.S.3.2	IMPURITY PROFILE
3.2.S.3.2.1	POTENTIAL IMPURITIES
3.2.S.3.2.2	ANALYSIS OF WORKING STANDARD FOR DETERMINATION OF POTENTIAL IMPURITIES
3.2.S.3.2.3	VALIDATION OF ANALYTICAL METHODOLOGY FOR THE ESTIMATION OF POTENTIAL IMPURITIES
3.2.S.3.2.4	RESIDUAL SOLVENT IMPURITIES
3.2.S.3.2.5	VALIDATION OF ANALYTICAL METHODOLOGY FOR THE ESTIMATION OF RESIDUAL SOLVENT IMPURITIES
3.2.S.4	CONTROL OF DRUG SUBSTANCE
3.2.S.4.1	SPECIFICATION
3.2.S.4.2	ANALYTICAL PROCEDURES
3.2.S.4.3	VALIDATION OF ANALYTICAL PROCEDURES
3.2.S.4.4	BATCH ANALYSIS
3.2.S.4.5	JUSTIFICATION OF SPECIFICATIONS
3.2.S.5	REFERENCE STANDARDS
3.2.S.6	CONTAINER CLOSURE SYSTEM
3.2.S.6.1	PACKAGING DETAILS
3.2.S.6.2	SPECIFICATION FOR PACKAGING MATERIAL
3.2.S.7	STABILITY
3.2.S.7.1	STABILITY SUMMARY AND CONCLUSIONS
3.2.S.7.2	POST APPROVAL STABILITY PROTOCOL AND STABILITY COMMITMENT
3.2.S.7.3	STABILITY DATA
	ANNEXURES