7IP PROCESS QUALITY CONTROL FOR DIFFERENT DOSAGE FORMS

IN PROCESS QUALITY CONTROL FOR DIFFERENT DOSAGE FORMS: 

IN PROCESS QUALITY CONTROL FOR DIFFERENT DOSAGE FORMS PRESENTED BY: VOHRA JAVED S. GUIDED BY: MR. DHARMENDRA BARIA DHARMAJ DEGREE PHARMACY COLLEGE,DHARMAJ DEPARTMENT OF QUALITY ASSURANCE 1

CONTENTS OF TOPIC: 

CONTENTS OF TOPIC DEFINITION OBJECTIVE USFDA c GMP GUIDELINES IPQC FOR: PARENTRAL PRODUCT SOLID DOSAGE FORMS (TABLT AND CAPSULE) SEMI-SOLID PREPARATION Liquid preparation COMPLETION STAGE RECORD AND REPORT DEPARTMENT OF QUALITY ASSURANCE 2

DEFINITION: 

DEFINITION It is a planned systems identify the material, equipment, processes and operators to enforce the flow of manufacturing and packaging operations according to the established rules and practices DEPARTMENT OF QUALITY ASSURANCE 3

OBJECTIVE: 

OBJECTIVE The primary objective of THE system is to monitor all the features of a product that may affect its quality and to prevent error during processing. The in process checking during manufacturing plays an important role in the auditing of the quality of the product at various stages of production. They are used to detect variation from the tolerance limits of the product so, that promote and corrective actions can be taken. DEPARTMENT OF QUALITY ASSURANCE 4

USFDA cGMP guidelines : 

USFDA cGMP guidelines To assure batch uniformity and integrity of drug product, written procedures shall be established and followed Valid in process specification for such characteristics shall be consistent with drug product In process material shall be tested for identity, strength, quality, and purity DEPARTMENT OF QUALITY ASSURANCE 5

PARENTRAL PRODUCT : 

PARENTRAL PRODUCT Checking the bulk solution before filling for drug content, pH, colour, clarity, and completeness of solution. Water for injection must pass Pyrogen test, Conductivity test Testing for leakage STERILIZATION Sterility testing : Culture media for sterility testing : 1-Fluid thioglycolate medium 2-Soyabean casein digest medium DEPARTMENT OF QUALITY ASSURANCE 6

Methods for testing: 1- Direct transfer method 2- Membrane transfer method to physical examination (visually or mechanically) for appearance, clarity and particulate contamination. Examining the sterility indicator placed in various areas of the sterilizer for each sterilization operation.: 

Methods for testing: 1- Direct transfer method 2- Membrane transfer method to physical examination (visually or mechanically) for appearance, clarity and particulate contamination. Examining the sterility indicator placed in various areas of the sterilizer for each sterilization operation. DEPARTMENT OF QUALITY ASSURANCE 7

SOLID DOSAGE FORMS : 

SOLID DOSAGE FORMS DRUG CONTENT UNIFORMITY AND RELEASE Weight variation DEPARTMENT OF QUALITY ASSURANCE 8

Disintegration test: 

Disintegration test DEPARTMENT OF QUALITY ASSURANCE 9 Types of tablets Disintegration time(min.) Uncoated table 15 Coated tablet 30-60 Enteric coated tablet 60 Dispersible and soluble tablet 3 Effervescent tablet 5

Dissolution test: Hardness: Friability:: 

Dissolution test: Hardness : Friability: DEPARTMENT OF QUALITY ASSURANCE 10

SEMI-SOLID PREPARATION: 

SEMI-SOLID PREPARATION uniformity and homogeneity of drug content. Determining the particle size. Checking the appearance, viscosity, specific gravity, sediment volume and other physical parameter at prescribed intervals. Test for penetration By wild Test for absorption By bliss DEPARTMENT OF QUALITY ASSURANCE 11

Rate of release of drugs 1) In vivo By skinner 2)In vitro By agar CUP- plate method: by ramsay-waud ◊Testing for leakage on the finished jars or tube : 

Rate of release of drugs 1) In vivo By skinner 2)In vitro By agar CUP- plate method: by ramsay-waud ◊Testing for leakage on the finished jars or tube DEPARTMENT OF QUALITY ASSURANCE 12

LIQUID DOSAGE FORM : 

LIQUID DOSAGE FORM IPQC FOR SYRUP Uniformity of content Uniformity of weight/volume Filled volume Ph test IPQC FOR EAR AND EYE DROP Uniformity of volume Particle size Sterility Filled volume DEPARTMENT OF QUALITY ASSURANCE 13

IPQC FOR SUSPENSION AND EMULSION: 

IPQC FOR SUSPENSION AND EMULSION COLOR CLARITY pH MEASUREMENT SEDIMENTATION RATIO EASE OF REDISPERSIBILITY DEPARTMENT OF QUALITY ASSURANCE 14

COMPLETION STAGE: 

COMPLETION STAGE At the completion of manufacturing process as well as in process stages, actual yield are checked against theoretic value and the representative sample are withdrawn for laboratory. testing by the control inspector according to the predetermined sampling plan. DEPARTMENT OF QUALITY ASSURANCE 15

RECORD AND REPORT : 

RECORD AND REPORT The batch production record and other needed document are then delivered to the quality control office together with the withdrawn samples of the products . DEPARTMENT OF QUALITY ASSURANCE 16

Label control: Production control issues a packaging from that carries: #The name of the product #Item number #Lot number #Packaging material to be used #Operation to be PERFOMED #Quality to be packaged #A copy of this form is sent to the supervisor of label control, who in turn counts out the required number of labels. : 

Label control: Production control issues a packaging from that carries: # The name of the product # Item number # Lot number # Packaging material to be used # Operation to be PERFOMED # Quality to be packaged # A copy of this form is sent to the supervisor of label control, who in turn counts out the required number of labels. DEPARTMENT OF QUALITY ASSURANCE 17

Packaging material control: 

Packaging material control Properties of the container tightness Moisture and vapour tightness regardless of container construction. Toxicity and chemical or physical characteristics of the materials needed in container construction. Compatibility between container and product. DEPARTMENT OF QUALITY ASSURANCE 18

References: 1) Lachman L., Lieberman H.:The Theory and practice of industrial pharmacy; 3rd edition-1987 P.N. 830-42 2)DR. Girish k jani,.:A Text book of pharmaceutics-2,B.S.SHAH prakashan, 8th edition-2008-09, P.N.130-275 : 

References: 1) Lachman L., Lieberman H.:The Theory and practice of industrial pharmacy; 3 rd edition-1987 P.N. 830-42 2) DR. Girish k jani,.:A Text book of pharmaceutics-2,B.S.SHAH prakashan , 8 th edition-2008-09, P.N.130-275 DEPARTMENT OF QUALITY ASSURANCE 19

THANK YOU FOR TOLERATED ME: 

THANK YOU FOR TOLERATED ME DEPARTMENT OF QUALITY ASSURANCE 20