Tag: Perth and Kinross

Question and Answer on Cleaning validation in Pharmaceutical Industry

Posted on By Pharmaceutical Guidanace

Question 1. What Is Cleaning Validation? Answer:   To evaluate the capability of cleaning procedure  in removing the drug residue and microbiological bio burden on equipment within established acceptance criteria, through the validation of cleaning procedures. To establish sufficient documented evidence to assure that, cleaning procedures can repeatedly and reproducibly remove residue of the subjected product…

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Quality Assurance

Stability Testing of New Drug Products ( Q1A(R2))

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Stability Testing of New Drug Products ( Q1A(R2)) The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance, results from stability studies on the drug substance, and experience gained from clinical formulation studies. The changes on storage and the rationale for the selection…

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Audit and Guideline

GLOSSARY AS PER STABILITY TESTING ICH GUIDELINE (Q1A(R2))

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GLOSSARY AS PER STABILITY TESTING ICH GUIDELINE (Q1A(R2)) Accelerated testing: Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Bracketing: The design of a stability schedule such that only samples on the extremes of certain design…

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Audit and Guideline

Stability Testing of New Drug Substances (ICH Q1A(R2))

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Stability Testing of New Drug Substances The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life…

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Audit and Guideline

VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY

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VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY INTRODUCTION This guideline is complementary to the parent guideline which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. In some cases (for example,demonstration of…

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Audit and Guideline

VALIDATION OF ANALYTICAL PROCEDURES (DEFINITIONS AND METHODOLOGY)

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VALIDATION OF ANALYTICAL PROCEDURES (DEFINITIONS AND METHODOLOGY) 1. INTRODUCTION This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required for registration in, or export…

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Audit and Guideline

GLOSSARY – Validation of Analytical Procedures

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GLOSSARY – Validation of Analytical Procedures 1. Analytical Procedure: The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration…

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Audit and Guideline

VALIDATION AND QUALIFICATION OF WATER PURIFICATION, STORAGE, AND DISTRIBUTION SYSTEMS AS PER USP

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WATER PURIFICATION -VALIDATION AND QUALIFICATION Establishing reliability of pharmaceutical water purification, storage, and distribution systems requires demonstrating control of the process through an appropriate period of monitoring and observation. Finished water is typically continuously produced and used, while product and process attributes may only be periodically assessed. The quality of bulk finished water cannot be established by…

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Audit and Guideline

ANALYTICAL INSTRUMENT QUALIFICATION

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ANALYTICAL INSTRUMENT QUALIFICATION A large variety of laboratory equipment, instruments, and computerized analytical systems  are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst’s objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures,…

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Audit and Guideline

Analytical Instrument Categories

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Analytical Instrument Categories Users are  establishing the level of qualification needed for an instrument. On the basis of the level needed, it is to categorize instruments into three groups: A, B, and C, as  for detail defined below. Examples of instruments in each group are provided. Note that the list of instruments provided here is for illustration…

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Audit and Guideline

PILOT SCALE UP AND PROCESS VALIDATION

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PILOT SCALE-UP AND PROCESS VALIDATION The development of the product before the preparation of the first pilot-production batch. The development activities are listed as follows: 1. Formulation design, selection, and optimization 2. Preparation of the first pilot-laboratory batch 3. Conduct initial accelerated stability testing 4. If the formulation is deemed stable, preparation of additional pilot…

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Validation & Qualification

WHAT IS PROCESS VALIDATION?

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WHAT IS PROCESS VALIDATION? The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment is often the result of an incomplete or faulty understanding of the process’s capability, in other words, what the process can and…

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Validation & Qualification

Master Plan or Protocol for Process Capability Design and Testing

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Master Plan or Protocol for Process Capability Design and Testing Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-process, finished product Definition of process output Potency, yield, physical parameters Definition of test methods Instrumentation, procedures, precision, and accuracy Process analysis Process variables,…

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Uncategorized

Checklist of Qualification and Control Documentation

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Checklist of Qualification and Control Documentation The FDA, as per existing cGMP regulations considers process validation necessary because it makes good engineering sense. Organization and personnel – Responsibilities of the quality control unit Buildings and facilities : Plant and facility installation and qualification Maintenance and sanitation Microbial and pest control Equipment: Installation and qualification of equipment and…

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Validation & Qualification

STATISTICAL PROCESS CONTROL AND PROCESS VALIDATION IN PHARMACEUTICALS

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STATISTICAL PROCESS CONTROL AND PROCESS VALIDATION IN PHARMACEUTICALS Statistical process control (SPC), also called statistical quality control and process validation (PV) SPC comprises the various mathematical tools (histogram, scatter diagram run chart, and control chart) used to monitor a manufacturing process and to keep it within in-process and final product specification limits. There are three ways of establishing quality…

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Validation & Qualification

Code to Code Transfer of Materials and Additional Testing of Materials / Products

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Code to Code Transfer of Materials and Additional Testing of Materials / Products Objective (procedure) To lay down a procedure for code transfer of the same material from one code to another and to carry out additional testing of APIs, Excipients, and Drug Products to comply with other specifications or Pharmacopoeia. Scope This standard operating…

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Quality Assurance

CALIBRATION MASTER PLAN

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CALIBRATION Calibration is an essential procedure that involves the adjustment and validation of measurement instruments to guarantee their accuracy and consistency in providing dependable results. This practice holds immense significance across diverse sectors including manufacturing, healthcare, research, and others. In the absence of meticulous calibration, errors can permeate throughout operations, resulting in subpar outcomes, escalated…

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Quality Assurance

SOP on In-process sampling of semi-finished product

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SOP on In-process sampling of semi-finished product Objective: To lay down the procedure for in-process sampling of semi finished drug product. Scope: This procedure is applicable to the in-process sampling of semi-finished drug product  in formulation plant of Pharmaceutical company. Responsibility: IPQA personnel are responsible for collecting in-process semi finished product samples. Production personnel are…

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Quality Assurance

SOP on execution of exhibit batches

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SOP on the execution of exhibit batches  Objective To lay down a procedure for the execution of exhibit batches. Scope This SOP is applicable for the execution of exhibit batches to the formulation plant of a Pharmaceutical company. Responsibility Officer/above of the production and quality assurance department shall be responsible. Accountability The Head of the…

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Quality Assurance

SOP on withdrawal, storage, observation & destruction of control/retention sample

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SOP on withdrawal, storage, observation & destruction of control/retention sample Objective: To lay down the procedure for withdrawal, storage, observation & destruction of control/retention sample from production (Oral & Injectable), Q.C. (RM Retention) . Scope: This SOP is applicable for the withdrawal, storage, observation & destruction of control samples from production (Oral & Injectable), and…

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Quality Assurance