PHARMACOVIGILANCE PLAN AS PER ICH Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug . Pharmacovigilance Plan that might be submitted at the time of licence application. Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that prefer this approach Pharmacovigilance Plan into the Common…
PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER OBJECTIVE:To lay down a procedure for microbiological monitoring of raw water and purified water. SCOPE:This SOP shall provide the procedure for sampling and testing of raw water and purified water from all the user points and all the points across the critical functions in the water purification process. RESPONSIBILITY…
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IN-PROCESS CONTROL OF PACKING LINE of TABLETS OBJECTIVE: To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall be applicable in-process controls during strip packing and final packing operation of tablets. RESPONSIBILITY: In process Quality Assurance Officer / Executive. ACCOUNTABILITY: Head Quality Assurance PROCEDURE: START UP Inspect the following…
INPROCESS CONTROL DURING TABLET MANUFACTURING OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE: This SOP shall be applicable for in process controls during tablets manufacturing. RESPONSIBILITY: In process Quality Assurance Executive/Officer. ACCOUNTABILITY: Head Quality Assurance. PROCEDURE: Carry out line clearance at each stage of operation prior to…
Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets Bill of Material Ingredient Quantity in kg Dextromethorphan Hydrobromide and Chlorphenamine Maleate complex 12.12*# Phenylephrine Hydrochloride complex 8.08**# Mannitol (Pearlitol SD200, Roquette) 42.80 Silica, Colloidal Anhydrous 2.00 Indion 294 3.00 Talc 0.50 Magnesium Stearate 0.75 Croscarmellose Sodium 3.00…
RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven bags with polybag inside Packed…
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International Organization for Standardization ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies.Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. The ISO is a multinational agency . It was established in 1947 as…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time PACKING [Released / Not Released / Hold / Rejected /…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time INSPECTION [Released / Not Released / Hold / Rejected / Not…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time COATING [Released / Not Released / Hold / Rejected / Not…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas /Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable]…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / Equipment Name Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time BLENDING [Released / Not Released / Hold / Rejected /…
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LINE CLEARANCE CHECKLIST FOR DISPENSING BOOTH Dosage Form: Date / Time: Product: Batch No. : Previous Product: Batch No. : Dispensing Booth No.: Sr. No. Check points Observations Done By Checked by Verified By QA Active Excipient Colour Production Warehouse Room Identification number: 1 Ensure the absence of batch documents, labels, materials or any…
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION Dosage Form: Tablet Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time GRANULATION [Released / Not Released / Hold / Rejected / Not…
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LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION Dosage Form: Date / Time: Product: Batch No. : Previous product: Batch No. : Stage areas / room & equipment Checks Checked by Production Date & Time Counter checked By Quality Assurance Date & Time BINDER PREPARATION [Released / Not Released / Hold / Rejected…
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LINE CLEARANCE CHECKLIST FOR DISPENSING AREA Dosage Form: Date / Time: Product: Batch No. : Previous Product: Batch No. : Dispensing Room: Sr. No. Check points Observations Done By Checked by Verified By QA Production Warehouse DISPENSING AREA [Released / Not Released / Hold / Rejected / Not Applicable] Room Identification number: 1 Ensure the…
Flow Chart and Manufacturing Procedure of Nimesulide Tablets Bill of Materials Ingredient Pharmacopoeial Status Pharmaceutical role Nimesulide Ph.Eur Active Lactose Monohydrate Ph.Eur. Diluent Croscarmellose Sodium Ph.Eur Disintegrant Silica, Colloidal Anhydrous Ph.Eur. Glidant Maize Starch Ph.Eur Diluent Povidone (K-30) Ph.Eur. Binder Docusate Sodium Ph.Eur. Surfactant Polysorbate 80 Ph.Eur. Surfactant Hydrochloric Acid,Concentrated Ph.Eur. pH Adjusting agent Water,…
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Non Conformance and Failure Investigation Checklist in pharmaceutical Products Product Name : Batch No. : …
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OOS Investigation Checklist Checklist for investigation of out of specification Sampling: Is performance against written procedure carried out? Are the cleaned sampling equipments used? Are the cleaned containers used for collection of samples? Is the sample integrity maintained until testing? Is composite sample prepared correctly? SAMPLE PREPARATION: Is correct weighing from correct portion of sample…
DATA INTEGRITY – QUESTIONS AND ANSWERS 1. Please clarify the following terms as they relate to CGMP records: 1.A) What is “data integrity”? Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). 1.B)What is “metadata”? Metadata is…
