SOP for Validation/Qualification Policy in Pharmaceutical Industry


  1. Objective:

To lay down a procedure for validation/qualification policy for equipment, system and instruments.

  1. Scope:

This procedure is applicable for production/engineering equipment, utilities and laboratory instruments.

  1. Responsibility:

Production, Quality Control, Engineering, other concerned department, Quality assurance

  1. Procedure:

4.1 For every new or existing equipment/instrument, consider below aspects:
– Whether equipment/instruments need to be validated.
– What will be the level of priority for the qualification/validation?
– What will be the revalidation/requalification frequency?
4.2 Identify the equipment/instrument which needs qualification or validation.
4.3 Evaluate the equipment as per below criteria:
Criteria I: GMP or regulatory agency recommendations.
Criteria II: Impact of failure on public health, usage of product and its criticality.
Criteria III: Safety and economic impact of the failure or breakdown of       equipment/instrument or process.
4.4 Decision of validation/qualification if required or not shall be based on above evaluation.
4.5 Fill the details of equipment or process to be qualified/validated in form. Form shall be approved by concern department head, engineering head and QA head.
4.6 Once equipment/instrument is decided to be qualified then its qualification priority level shall be determined as following:
Level I: Equipment/instrument used for critical process e.g. Mixing vessel, HPLC etc or       provide clean air, water or controlled environment for manufacturing or required for       testing of critical quality parameters of products.
Level II: Equipment used for simple and less complex process such as sifting, milling,       binder preparation etc. and used as ancillary equipment with level I equipment or       laboratory instruments which are used for physical parameters and for which calibration is sufficient to ensure its performance.
4.7 All newly purchased level I equipment/instrument shall be qualified/validated before use and level II equipment/instrument shall be calibrated before use.
4.8 Designated person from QA shall prepare qualification/validation plan for every year.
4.9 Qualification/validation plan shall be maintained with VMP.
4.10 Requalification of existing equipment/instrument:
4.10.1 Any major change in existing system/ equipment or change in its operational range, the respective equipment shall be qualified as per scope of change and approved   protocol.
4.10.2 Periodic qualification shall be performed even if there is no change in equipment. 
Level I equipment shall be requalified in every 5 years and level II equipment shall be      requalified in every 10 years.
4.10.3 Analytical instrument irrespective of priority I and II shall be qualified in case of
major changes. However, calibration shall be performed as per pre-defined frequency.
4.10.4 Requalification schedule shall be maintained.
4.11 Periodic performance checks (Revalidation):
4.11.1 Some of the equipment/system shall be periodically checked for its performance.    Based on that performance checks plan shall be prepared.
4.11.2 All the documents related to validation and qualification shall be retained by QA.

  1. Abbreviations:

VMP: Validation Master Plan
QA: Quality assurance
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