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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 …

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 …

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 …

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 …

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 …

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 …

PILOT SCALE-UP AND PROCESS VALIDATION The development of product prior to 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 …

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 incomplete or faulty understanding of the process’s capability, in other words, what …

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 …

Checklist of Qualification and Control Documentation The FDA, as per existing cGMP regulations and 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 …

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 …

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 …

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, …

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 …

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. …

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 …