LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT GRANULATION

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 … Read more

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BINDER PREPARATION

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 … Read more

LINE CLEARANCE CHECKLIST FOR DISPENSING AREA

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 … Read more

Flow Chart and Manufacturing Procedure of Nimesulide Tablets

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, … Read more

OOS Investigation Checklist

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 … Read more

DATA INTEGRITY – QUESTIONS AND ANSWERS

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 … Read more

Data Integrity Guidance in Pharmaceuticals

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 … Read more

Training Requirements for Audit and Routine Practices in Pharmaceuticals

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 … Read more

Personal Hygiene Checklist for Audit and Routine Practices in Pharmaceuticals

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 … Read more

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