SIX SYSTEM INSPECTION MODEL
Presented by:
Brajesh kumar panda
M. Pharm (Quality Assurance) 1st semester
ISF Collage of Pharmacy, Moga, Punjab.
Contents:
Introduction
Objective of the programme
Strategy for Inspection
Six system inspection model
I. Quality Management System
II. Production System
III. Facility and Equipment System
Introduction:
• It is a model that can help pharmaceutical manufacturers comply with
CGMP regulation.
• CGMP refers to the Current Good Manufacturing Practice regulations
enforced by the FDA.
• CGMPs provide for systems that assure proper design, monitoring,
and control of manufacturing processes and facilities.
Objective of the Programme :
• The goal of this program's activities is to ensure that establishments
consistently manufacture drug products of acceptable quality and
minimize consumers' exposure to adulterated drug products.
• To determine whether establishments work according to the given
cGMP requirements and if not, to take actions against the adulterated
products and to restrict them from releasing.
• To better understand the manufacturing practices according to cGMP,
Regulatory policy, etc.
Strategy for Inspection:
• Control of all these systems helps ensure the firm will
produce drugs that are safe. have the identity and
strength, quality and purity characteristics as intended.
• Inspections of drug manufactures should be made and
reported using the system definitions and industry
codes in this compliance program
Six system inspection
model:
• Quality Management System
• Production System
• Facility and Equipment System
• Laboratory Control System
• Materials System,
• Packaging and Labeling System
Quality Management System:
• This system assures overall compliance with CGMPs and internal procedures and
specifications. This system includes the quality control unit and all of its review and
approval duties.
• Carried out in two phase.
first phase evaluation of whether the Quality Control Unit has fulfilled the
responsibility to review and approve all procedures related to production, quality
control, and quality assurance and assure the procedures are adequate for their
intended use is done.
Second phase is to assess the data collected to identify quality problems which may
link to other major systems for inspectional coverage.
• The firm should have written and approved procedures and documents which are
inspected in this system.
• Product reviews.
• Complaint reviews.
• Discrepancy and failure investigations related
to manufacturing and testing
• Change Control.
• Production improvement projects.
• Returns .
• Validation.
• Training/qualification of employees in quality
control unit
Production System:
• This system includes measures and activities to manufacture control
the manufacture of drugs and drug products including batch
compounding, dosage form production, in-process sampling and
testing, and process validation.
• It also includes establishing, following, and documenting performance
of approved manufacturing procedures.
• control system for implementing changes in processes.
• adequate procedure and practice for charge-in of components .
• identification of equipment with contents, and where appropriate
phase of manufacturing and/or status
• validation and verification of cleaning/sterilization/ depyrogenation
of containers and closures.
• calculation and documentation of actual yields and percentage of
theoretical yields.
• complete batch production documentation
• adherence to preprocessing procedures (e.g. set-up, line, clearance )
Facility and Equipment System:
• This system ensures the appropriate physical environment for the
production of pharmaceutical products, such as buildings and facilities
along With maintenance ; Equipment Qualification Utilities which is
not used directly in product.
• There is a written and approved procedures for each thing included in
this system which should be followed strictly according to cGMP.
• When this system is selected for coverage in addition to the Quality
System, all areas listed further should be covered: however, the depth
of coverage may vary depending upon inspectional findings.
• cleaning Maintenance.
• Cross contamination.
• General Air handling systems
• Equipment installation , qualification, design, size and location.
• Cleaning procedures and validation.
• Control systems
• Appropriate use of equipment operations substances
• Documented investigation into any unexpected discrepancy.
THANK YOU
