Tag Archives: greece

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST

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 …

Read More »

International Organization for Standardization

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 …

Read More »

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING

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 …

Read More »

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR INSPECTION LINE

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 / …

Read More »

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COATING

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 / …

Read More »

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR COMPRESSION

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 …

Read More »

LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR BLENDING

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 …

Read More »

Education in Ukraine offers Courses & Fees

Education in Ukraine offers Courses & Fees   Sumy State University (SSU), Sumy Courses & Fees B.Tech. (Bachelor of Technology) Available Courses Course Name Duration Fees(Annual) BA in Mechanical engineering 4.0 Years  1.21 Lacs BA in Heat and power engineering 4.0 Years  1.21 Lacs BA in Engineering Materials Science 4.0 …

Read More »

LINE CLEARANCE CHECKLIST FOR DISPENSING BOOTH

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 …

Read More »

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 / …

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 …

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 …

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 …

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 …

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). …

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 …

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 …

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, …

Read More »

Manufacturing Procedure of Ornidazole Tablets

 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 …

Read More »