Validation policy:

Scope :

Responsibilities:

Production department :

 Implementation of the protocol for confirmation, equipment and procedure tests.

 Training of technological validation and GMP considerations for all production staff.
 Process monitor sampling and implementation in conjunction with QA
 Preparing reports or other process criteria deviations.
 Taking part in the creation of parameters of validation.
 Attempting to run (PQ) and running assistant protocols (DQ, IQ, and OQ).

Department of Quality Control:

 Validation sample testing.

 Ensuring the qualification or validation of lab systems and instruments to be used during
validation.
 Conduct validation of analytical methods.
 Preparation of information on any variations in analytical specifications.
 Taking part in the creation of protocols of validation.
 Training in the technological, validation and GMP fields of all quality control staff.
 Preparation of laboratory findings and conclusions summaries

Engineering Department:

 Participating in the development of protocols for validation.

 Preparation of designs and relevant materials for systems engineering including P and
I diagrams, instrument listing, construction and area diagrams, manuals of operation,
operational instructions, specifications of service, catalogue of replacement
components, Manuals of activity
 Identification of component of equipment, material control procedures, calibration
standards and assembly and system design techniques and procedure for equipment.
 Coordinating the calibration exercises for all essential instrumentation.

Quality Assurance:

 Coordination of initiatives to identify the system/equipment and devices to be

validated.
 The validation team shall be coordinated and organised.
  Coordinate the planning and implementation of validation procedures for each
system.
 Doing validation of the method by tracking, sampling, checking and challenges of a
particular manufacturing operation
 Staff education in validation/operations assistance.
 Participation in the creation of protocols to validate.
 Validation data collection and management.
 Preparation of final validation overviews and declarations of approval.
 Monitor the validation specification for routine/non regular.

Facility:

Instrumentation Room (Quality control), quality assurance , chemicals stored room ,

pharmaceutics laboratory ,(formulation Room ), pharmacology laboratory,

Equipment and utility:

 High performance liquid chromatography (HPLC) –isocratic and gradient

 UV-spectrophotometer
 Autoclave
 Dissolution
 Friability apparatus
 Disintegration apparatus
 FTIR spectrophotometer
 Stability chamber
 Water system

User requirement specifications: