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…
Data Integrity Guidance Good data management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable. The organisational culture should ensure data is complete, consistent and accurate in all its forms, i.e. paper and electronic Organisations are not expected to implement a forensic…
Training Requirements for Audit and Routine Practices in Pharmaceuticals Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in…
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Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of drug products. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become…
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Manufacturing Procedure of Ornidazole Tablets Bill of Material Ingredient Pharmaceutical role Ornidazole Active Microcrystalline Cellulose Diluent Lactose Monohydrate Diluent Silica, Colloidal Anhydrous Surfactant Povidone (K-30) Binder Water, Purified Vehicle Sodium Lauryl sulphate Surfactant Talc Granular former Magnesium Stearate Lubricant Croscarmellose Sodium Disintegrating Opadry Green Coloring Agent Manufacturing Procedure Step – I:-Sift, Lactose Monohydrate, Silica,…
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Manufacturing Procedure of Metformin Hydrochloride Extended-Release Tablets USP 1000 mg Bill of Material: Batch Size:- 100000 Tablets Ingredient Standard Quantity Per batch In kg METFORMIN HYDROCHLORIDE 100.60* CARMELLOSE SODIUM 10.00 PURIFIED WATER 18.60 HYPROMELLOSE 26.00 CELLULOSE,MICROCRYSTALLINE (DIRECTLY COMPRESSIBLE,PH 102) 9.5 MAGNESIUM STEARATE 1.5 POVIDONE 1.5 SILICA , COLLOIDAL .ANHYDROUS 1.5 * Given quantity of Metformin…
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS – GENERAL Sec. 210.1-Status of current good manufacturing practice regulations (a) The minimum current good manufacturing practice for methods to be used in the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that…
Validation of Sterilization Process in Autoclave VALIDATION PROTOCOL Validation of Sterilization Process in Autoclave (Loaded chamber) Purpose: To provide the procedures to be followed for study of heat distribution studies in the loaded chamber of Autoclave. Scope: This procedure is applied to all Autoclaves used to sterilize Containers or Equipment used for the aseptic processing…
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Procedure for measurement of fill weight during batch filling Objective: To lay down the procedure for measurement of fill weight during batch filling. Scope: This SOP is applicable for measurement of fill weight during batch filling in Injectable department. Responsibility: Operators/Technician – Responsible for measurement of fill weight during batch filling. Executive /Officers production –…
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Manufacturing Process Development as per ICH -Q11 The approaches to developing and understanding the manufacturing process of the drug substance, and provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2 –3.2.S.2.6 (ICH M4Q). All the aspects of development and manufacture that pertain to drug substance, including the presence…
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Stability Chamber Stability Chambers serve as specialized equipment used for testing various products and determining their shelf life, such as drugs, electrical components, and industrial materials. These chambers allow for the adjustment of parameters like temperature and humidity to conduct thorough checks under different conditions. Since different products require specific testing conditions, it is not…
DISINFECTANT VALIDATION To evaluate the efficiency of disinfectants that are being used for the surface and area sanitization of controlled and critical clean rooms. The disinfectants when used as per the recommendations of the manufacturer for dilution and the contact time should be able to inhibit the growth of the test microorganisms. TABLE OF CONTENTS…
PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM OBJECTIVE The objective of this study is to determine the efficacy of UV germicidal lamp of Laminar air flow and pass box with known microorganism. This ensures that the UV is effective enough to kill the microorganisms on exposure to a defined period and…
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Unit Dose Sampling Procedure for Blend Uniformity OBJECTIVE To lay down the procedure for collecting unit dose blend samples for evaluation of blend uniformity so as to ensure accurate and consistent sampling. RESPONSIBILITY : Officer – Quality Assurance to collect the samples. Head of Quality Assurance to ensure compliance. PROCEDURE: Unit dose sampling procedure for…
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