Process validation concept for the pharmaceutical industry

Validation concept
In accordance with GFD validation definition is "Establish documented evidence that provides a high degree of assurance that a specific process will always produce a product that meets its predetermined specifications and quality attributes."

Appropriate and comprehensive documentation is recognized as being essential for validating data. Standard Operating Procedures (SOPs), manufacturing formulas, detailed batch documentation, change control systems, survey reporting systems, analytical documentation, development reports, protocol validation, and reports are an integral part of the validation philosophy. The validation documentation is a source of information for the ongoing operation of the installation and is a resource that is used in the subsequent development process or modification activities.

All validation activities will include a level impact assessment to ensure that the systems, services and products directly influenced by the testing have been identified.

A revalidation program must be implemented based on routine equipment revalidation requirements and on the change control policy.

Types of Validation

Prospective validation
Establishing documented evidence that a piece of equipment / process or system will do what it is supposed to do, based on a series of pre-planned scientific tests as defined in the validation plan.

Simultaneous validation
When using an existing method can be localized to be in a state of control by applying tests on samples at strategic points through a process, and at the end of the process. All data are collected at the same time as the implementation of the procedure until the available information is sufficient to demonstrate reproducibility of the process.

Retrospective validation
Establishing documented evidence that a process is doing what it is supposed to do, based on the review and analysis of historical data.

Qualification Design (DQ)
The purpose of the DQ is fulfilled during design and commissioning by a number of mechanisms including:

- Generation of specification of user requirements
- Verification that the design meets the relevant specifications of user requirements.
Assessment Provider / Audits -
- The challenge of designing by GMP exam audits
- Evaluation of the impact of quality products
- Specification of hardware vendor validation documentation requirements
- Agreement with suppliers on performance objectives
- Factory acceptance testing (FAT), Site Acceptance Test (SAT) and commissioning procedures
- Definition of the construction and installation documentation to assist in qualification of the installation (IQ).

Installation Qualification (IQ)
IQ provides documented evidence that this equipment or system has been developed, supplied and installed in accordance with the technical drawings, supplier's advice and In-house requirements. In addition, the IQ ensures that the file of the main characteristics of the equipment or system, as installed, is available and that it is supported by adequate documentation sufficient to allow satisfactory operation of control. maintenance and change to implement.

Operational Qualification (OQ)
OQ provides documented evidence that the equipment operates as intended throughout the specific, operational design or acceptance limits of the approved equipment, if applicable. In cases where the process steps are tested, an appropriate placebo lot will be used to demonstrate the functionality of the equipment.
All new equipment must be fully commissioned before the start OQ to ensure that, at a minimum, the equipment is safe to operate, all mechanical assembly and pre-qualification checks have been performed, that the equipment is fully functional and that the documentation is complete.

Performance Qualification (PQ)
The purpose of PQ is to provide documented evidence that the equipment can still achieve and maintain its performance specifications over an extended period of operation at a defined operating point to produce a product of predetermined quality. The performance specifications will reference process parameters, in-process and product specifications. PQ requires three batches of products to meet all of the acceptance criteria for in-process and on-product. For utility systems, PQ requires utility support to meet all specifications during an extended sampling period.

The PQ documentation must refer to standard manufacturing processes and batch records and describe the sampling and testing methodology to be used.

What is validated
General
All process steps, production equipment, systems and the environment directly used for the production of sterile and non-sterile products must be formally validated.

All major packaging material and processes must be validated. This validation is less complete.
All ancillary systems that do not directly relate to the impact on the quality of the product must be qualified by means of technical documentation of the extent of the system and how it works.

Ease
- Area Design Manufacturing.
- Staff and material flows, etc.

Equipment design process and
The stages of the process and the description of the equipment. ie distribution, formulation, washing of packaging equipment,
and cleaning. etc.

System Design Utility
Raw / purified steam, purified water, etc. Compressed air waste, air conditioning system, vacuum, power supply, lighting, cooling water,

Computerized Systems Design
Information system, automated laboratory equipment, automated equipment manufacturing, electronic records etc.

Cleaning validation (CV)
CV provides documented evidence that a cleaning procedure is effective in reducing the pre-defined maximum allowable limits, all chemicals and microbiological contamination of a piece of equipment or manufacturing area after treatment. The means to evaluate cleaning efficiency involves sampling cleaned and sanitized surfaces, and checking the level of residues of cleaning products and residues of bacterial contamination.

The term CV is used to describe the analytical study of a cleaning or cycle procedure. Validation protocols should refer to the basic documentation of the "worst case" justification for testing when it is proposed. It should also explain the development of acceptance criteria, including chemical and microbial specifications, detection limits and selection of sampling methods.

Validation of the method (MV)
MV provides documented evidence that internally developed test methods are accurate, robust, efficient, reproducible and repeatable. Validation protocols should refer to the basic documentation of the rationale for determining sensitivity limits for the detection and method.

Computer validation
Computer validation provides documented evidence to ensure systems will always operate according to their predetermined specifications and quality attributes, throughout their life cycle. Important aspects of this validation approach are the formal management of the design (through a specification process), the quality system (through systematic review and testing); risk (through identification and assessment of novelty and critical functionality) and life cycle (through control of lasting changes).

When the equipment is controlled by integrated computer systems, computer validation elements can be performed as part of the IQ OQ equipment and protocols ....