Validation and Qualification Facility System and Equipment

1.0 Objective
1.1 To lay down a procedure for Validation & Qualification of System, Equipment’s and Facility.
2.0 Scope
2.1 This Standard Operating Procedure is applicable for Validation & Qualification of System,

Equipment’s and Facility to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer/Executive of all departments shall be responsible for following the procedure as per SOP.
3.2 Concerned department Head/Head QA / his or her designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
cGMP : Current Good Manufacturing Practices
FDA : Food and Drug Administration
HEPA : High Efficiency Particulate Air
HVAC : Heating, Ventilation and Air-Conditioning
IQ : Installation Qualification
OQ : Operation Qualification
PQ : Performance Qualification
BPCR : Batch Production & Control record
CCF : Change Control Form
5.0 Procedure
5.1 To perform Validation and Qualifications, we have “Validation Policy” The objective of Validation Policy is
5.1.1 To draw out a Validation Master Plan
5.1.2 To evolve generic validation protocols.
5.1.3 To update validation methodologies/ techniques and documentation
5.1.4 To maintain inventory of validation and related documents
5.1.5 To describe the methodology for review of validations
5.1.6 Validation is defined as the documented act of proving that any procedure, process,

equipment, material, activity, or system will consistently lead to the expected result.
5.2 To perform validation, “Validation Master Plan” shall be made by QA.
5.2.1 The objective of Validation Master Plan is to describe a logical sequence of Validation activities.
5.2.2 T establish means to remain in a “State of Validation”.
5.3 Validation Master Plan describes the plan for various systems to be validated such as
5.3.1 Production Systems
5.3.2 Engineering and Utilities Systems
5.3.3 Warehouse
5.3.4 Describes what, why, when and how a validation and qualification activity is to be performed.
5.3.5 Validation Master Plan described the methodology to define the acceptance criteria and revision

of validation protocols.
5.4 QA shall perform Validation and Qualification of following systems to establish Documentary

evidence which provides a high degree of assurance that specific process/Equipment/system will

consistently produce/deliver/provide a product/performance/ service Meeting its predetermined

Specifications and quality attributes.
5.4.1 Manufacturing Processes
5.4.2 Equipment
5.4.3 Utilities
5.4.4 Water Systems, Air Systems, Nitrogen Systems etc.
5.4.5 Analytical Methods
5.4.6 Warehouse Systems
5.4.7 Cleaning Procedure
5.4.8 Any other system which is recognized as important and can have impact on process, quality.
5.4.9 Purity and potency of the drug substance.
5.5 QA shall perform Validation and Qualification at the time of Commissioning of new plant or lab/equipment.
5.5.1 Introduction of new process/product
5.5.2 Introduction of new analytical method
5.5.3 Change in the manufacturing process
5.5.4 Change in the analytical method
5.5.5 Change in equipment/system
5.5.6 Change in manufacturing site
5.5.7 Change in operating personnel
5.6 Validation shall be performed to describe
5.6.1 The manufacturing process, equipment or system configuration
5.6.2 Define overview, objective of validation/ qualification activity
5.6.3 Discuss validation/ qualification procedure to be followed
5.6.4 Define acceptance criteria
5.6.5 Construct the validation protocol
5.6.6 Training to the doers
5.6.7 Starting the activity
5.6.8 Collection of data
5.6.9 Interpretation of data
5.6.10 Compilation of report
5.6.11 Review and approval
5.7 Validation & Qualification of Production Systems
IQ/OQ/PQ for new production equipment shall be carried out to verify that a specific piece of

Equipment/system is suitable for its intended purpose and has been installed properly.

In addition, equipment/ system shall be evaluated to determine their operating limits.

These Qualifications shall be carried out by executing approved IQ, OQ and PQ protocols.

Whenever an existing equipment/ system is to be used for manufacturing a new product,

it shall be qualified for proposed application. This will be performed as per current

protocol for “qualifying suitability of Existing equipment/ system used in manufacturing”.
5.8 Validation & Qualification of Engineering and Utilities Systems
IQ/OQ/PQ for all critical new equipment shall be performed by executing current,

approved and established protocols.
Prospective Validation for new installed and commissioned water system.
Concurrent Validation for new water system already validated prospectively.

This shall be performed by using the current approved protocol.
5.9 Analytical Method Validation
5.9.1 Validations of non-compendial analytical methods are received from Analytical Research-R&D.
5.10 Validation of HVAC System
5.10.1 QA shall identify all the components of an HVAC system and their functionality.
5.10.2 Identify all the AHUs supplying filtered air o various areas.
5.10.3 Make a diagram of the complete HVA system in the plant.
5.10.4 Perform IQ, OQ and PQ of the HVAC system, using current, approved and established protocols.
5.10.5 Conduct revalidation if there is any major change in the parameters/ specification/equipment.
5.11 Validation-Expectations From Quality Assurance:
The following are the expectations from Operating Manager of each area related to Validation Systems:
5.11.1 Totally familiarize with the “Validation Master Plan” to identify various validation

or qualification activities required to be performed in the current year.
5.11.2 Completely understand all the existing validation or qualification protocols which are

followed for conducting validation of identified units or systems.
5.11.3 Write new validation or qualification protocols on the units or system as per the current “SOP on Writing and Release of Validation/Qualification Protocols”.
5.11.4 Complete the validations or qualifications of units/systems, with in the specified time frame.
5.11.5 Give a unique document number to each Validation and Qualification report and archive

them in the plant, after approval. Train the concerned Officer/Executive on validation systems.
6.0 Forms and Records
6.1 None

7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance, Production, Quality Control, Warehouse & Engineering
8.0 History