User Requirement Specification for Automatic Capsule Filing Machine

1.0 APPROVAL The user requirement specification for Automatic Capsule Filing Machine for filling the bulks...

Qualification Vs Validation Difference

Good Manufacturing Practices for Pharmaceutical Products

1. Pharmaceutical Quality System (PQS): 1.1. The manufacturer must assume responsibility for the quality of...

Site Master File (SMF) Preparation Guidelines

What is SMF : A Site Master File (SMF) is a document that describes the...

Pharmaceutical Stability Testing Guide

What is Stability Testing : Stability testing is the process by which pharmaceutical manufacturers observe...

Environmental Monitoring in Pharmaceutical Industry

Environmental Monitoring in Pharma Industry means the process of regularly testing and analyzing the air,...

Solid Oral Manufacturing Area Risk Assessment Reports

Sr. No. Risk identification Probability of Occurrence Severity Detection Risk Probability Number (RPN) Current control...

72 numbers Pharmaceutical Industry Production interview Questions & Answers

What is Production : All operations involved in the preparation of a pharmaceutical product, from receipt...

User Requirement Specification for Auto-Coater

User Requirement Specification for Blister Packing Machine

User Requirement Specification for Strip Packing Machine

52 numbers Interview Questions and Answers for Quality Control in Pharmaceutical

What is Quality Control : The term quality control refers to the sum of all procedures undertaken...

Change control Vs Deviation Difference

Corrective Action and Preventive Action (CAPA) Questions and Answers

1. What is CAPA & why CAPA taken : Corrective Action:                                                   An action taken to...

Deviation Related Questions and Answers

1. What is Deviation: Any unwanted event that represents a departure from approved processes or...

Change control Questions and Answers

1. What is Change Control: Any planned permanent or temporary departure or modification or addition...

Importance of Preventive Maintenance in Pharmaceutical Industry

What is Preventive Maintenance : Preventive maintenance is the maintenance that is regularly performed on...

Engineering Department Responsibility in Pharmaceuticals

Below are the responsibilities of Engineering personnel in Pharmaceutical Industry (But not limited To) 1....

Principle and working of Fluidized Bed Dryer (FBD)

What is Fluid Bed Dryer : FBD is used for drying of different pharmaceutical materials...

Working and Principle of Tablet Compression Machine

What is Tablet Compression Machine: A tablet press is a mechanical device that compresses powder into tablets of uniform size and...

Common tablet Defects

Training of Plant Personnel

OBJECTIVE To lay down the procedure for training of the personnel through Training Information Management...

Procedure for Sampling, Storage and Destruction of the Reference Samples

1.0 OBJECTIVE  To lay down the procedure for Sampling, Storage and Destruction of the Reference...

Annual Product Quality Review (APQR)

OBJECTIVE To lay down a procedure to review and evaluate the need for any change...

Process Validation

OBJECTIVE To lay down specific procedure for product / process validation of new as well...

Product Recall Procedure in Pharmaceuticals

WHAT IS PRODUCT RECALL: Removal or correction of marketed products for the reasons relating to...

Change Control in Pharmaceutical Industry

What is Change Control : Any planned permanent or temporary departure or modification or addition...

Deviation in Pharmaceutical Industry

DEVIATION: Deviation is an unexpected event that occurs during the on-going operation/Activity/ Documentation / Entries...

Handling of Market Complaint in Pharmaceutical Industry

MARKET COMPLAINTS A complaint is any expression of dissatisfaction with a product or service marketed....

Analytical Method Validation

Method validation : It is the process which is used to confirm that the analytical...

Process Validation in Pharmaceutical Manufacturing

What is Process Validation : Process validation is defined as the collection and evaluation of...

Warehouse Interview Questions and Answers in Pharmaceuticals

What is the role of Warehouse in Pharmaceuticals: Warehouse in pharmaceutical plays an important role...

Change Control Form

Hi, Here I have attached the change control Form which will be applicable for Regulatory...

Deviation Request Form in Pharmaceutical

Hi, Deviation Request Form is attached for your reference and this can be used as...

Performance Qualification (PQ) Report of Dissolution Test Apparatus

Performance Qualification of Dissolution Test Apparatus is attached for your Reference.   Performance Qualification (PQ)...

Out of Trend (OOT) Investigation Format

Out of Trend (OOT) Investigation Format is attached for Reference Fire Boltt Talk 2 pro...

Performance Qualification Report of HPLC

Market Compliant Investigation Report of Powder Leaking from Sealed Capsule

Potable Water Specification

Purified Water Specification as Per IP/BP/USP/Ph.Eur/Inhouse

Microbiology SOPs Index

Hi, The list of Microbiology SOPs are given for your reference and and interested persons...

Quality Control Instruments Qualification Documents

Hi, The list of Instruments Qualification Documents  ( but not limited to) are given and...

Warehouse Department SOPs Index

Hi, Warehouse Department SOPs Index is attached and interested persons can contact me on cspandapharmaconsultant@gmail.com...

Consultancy Services

This is Chandrasekhar Panda with more than 18 years of experience in Pharmaceutical industry Quality...

Ointment Batch Manufacturing and Packing Record

Please find the attachment of Ointment Batch Manufacturing and Packing Record Ointment-BMR and BPR