Activity 6

Roque Click to edit Master subtitle style Santos Sobrevega Solano

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SCHEMATIC DIAGRAM

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Checks shall be carried to ensure that the work area and equipment are clean and free from any products, product residues or documents not required for the operation

Coding of Components (batch number, lot number, exp date and manuf date) Quarantine (yellow tag)

QC approved (green tag)

QC reject(red tag)

Line Clearance Placement of Materials to packaging lines In Process Quality Control

Product fill At regular intervals

Reworking/Reprinting

Check the last production package to confirm conformance to the master packaging procedure Reconciliation
Destruction or return of the unused materials Documentation

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Checks performed during production in order to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or API conforms to its specifications.

IPQC
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a) Drug contents determination. b) Moisture contents of granules. c) Assay of active ingredients. d) Weight variation of uncoated tablets. e) Hardness test. f) Disintegration test.

IPQC TESTS FOR TABLETS:

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a) Drug contents determination. b) Assay of active ingredients. c) pH. d) Weight per ml. e) particle size

FOR SYRUPS AND SUSPENSIONS:

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a) Drug contents determination. b) Assay of active ingredients. c) Uniformity and homogeneity test. d) Viscosity and specific gravity test. e) Filling test. f) Leakage test.

FOR SEMI-SOLIDS:
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a) Drug contents determination. b) Assay of active ingredients. c) pH. d) Pyrogen test. e) Stability test. f) Leakage test. g) Check up of particulate matters.

FOR INJECTABLES:
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Documents

Click to edit Master subtitle style

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is a document from which copies are made for use in the packaging of individual batches of product Shall outline a complete and detail procedure and instructions for packaging Shall provide a blank space or form for recording the packaging data. Prepared and signed by production manager and countersigned by quality control manager. .

Master Packaging Procedure

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Shall include the following: Product name, dosage form and strength Description of the container, closures and other packaging materials Procedure for reconciliation of the issued quantities in bulk product and packaging materials with the number of units packs. Produced Statement of the theoretical and percentage limit of the actual yield Packaging line and equipment to be used

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Record kept for each batch processed Based on the master or specifications (e.g. copied to avoid errors) Check suitability of area and equipment clear of previous products, documents, materials Checks recorded

Batch Processing Record

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Name of the product, batch number Dates and times (e.g. start, major steps, completion) Name of person responsible for each stage of production Name of operators carrying out each step (check signatures)

Information recorded during processing includes:

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Theoretical quantities for materials in the batch Reference number and quantity of materials used in the batch Main processing steps and key equipment In-process controls carried out, person's initials, and results obtained

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Yield at each stage with comments on deviations Expected final yield with acceptable limits Comments on any deviations from process Area clearance check, instructions to operators Record of activities

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Thank you for listening!

Click to edit Master subtitle style

8/3/12