Audit and Guideline

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 …

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 …

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 / …

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 / …

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 …

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 …

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 …

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 / …

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 …

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 …

Non Conformance and Failure Investigation Checklist in pharmaceutical Products Product Name                :                                           Batch No.  :                  …

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 …

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). …

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 …

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 …

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, …

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 …

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 …

Process analytical technology (PAT) — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance PAT FRAMEWORK PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final …

Pass Box for Clean room and it validation Definitions of Pass Box: Pass Box is specifically designed that aids in the material transfer without much personnel movement in clean rooms and also work like a barrier between classified and unclassified area.two types of pass box is used in pharmaceutical industry that …