SHORT SEMINAR ON cGMP

1. Presented by : Mr. Pradipkumar G. Rathod
M. Pharm 1st year (1st sem.) (Pharmaceutics)
University Department of Pharmaceutical sciences,
R.T.M. Nagpur University, Nagpur.

2. Contents :
 Introduction
 Principles of GMP
 Role of GMP with respect to Quality Management
 Role of GMP with respect to Personnel
 Subpart C- Building and facilities
 Subpart D: Equipment
 Subpart F : Production and process control
 Subpart G: Packaging and Labelling control
 Quality Control ( Subpart I: Laboratory Control)

3. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food
and Drug Administration (FDA).
cGMP provide systems that assure proper design, monitoring, and control of manufacturing
processes and facilities.
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug
products by requiring that manufacturers of medications adequately control manufacturing
operations.
This includes establishing strong quality management systems, obtaining appropriate quality raw
materials, establishing robust operating procedures, detecting and investigating product quality
deviations, and maintaining reliable testing laboratories.
This formal system of controls at a pharmaceutical company, if adequately put into practice, helps
to prevent instances of contamination, mix-ups, deviations, failures, and errors.
This assures that drug products meet their quality standards.

4. What is CFR (Code of federal Regulations ), published by Federal government
In CFR total 50 Chapters
Chapter 3 : For US president
Chapter 50: For Fisheries & Wild life preservation
Chapter 21 : For Food & Drug manufacturing.
The US GMP regulations are divided into two parts: 210 and 211, Title 21.
• Part 210, “Current Good Manufacturing Practices in manufacturing, Processing. Packing or Holding
of Drugs “, basically it provides the framework for the regulation.
• Part 211, “ Current good manufacturing practices for finished pharmaceuticals.
• The part 211 is further divided into 11 subparts ,Subpart A to Subpart K.
Definition of GMP as per WHO: GMP is that part of quality assurance, which ensures that
products are consistently produced and controlled to the quality standards appropriate to their
intended use and as required by the marketing authorization.

5. Content of part 211 of US GMP regulation:
• Subpart A : General Provision
• Subpart B : Organization and personnel
• Subpart C : Buildings and Facilities
• Subpart D: Equipment's.
• Subpart E : Control of components and Drug product containers and closures
• Subpart F : Production and process controls
• Subpart G: Packaging and labeling Control.
• Subpart H :Holdings and Distribution
• Subpart I: Laboratory Control .
• Subpart J: Records and reports
• Subpart K: Returned and savaged drug products.

6. Principles of GMP
• To harmonize the manufacturing procedures globally with a marked standard, which
assures that the product is been manufactures in a good facility and a quality product.
• It Provide the frame of SISPQ , i.e. Safety, Identity, Strength, quality, and Potency to
a drug product.
• GMP is based on the controlled production of the drug products, under the federal
Food , Drug and Cosmetic act, which states that , “ A drug products will be deemed to
be adulterated unless the method used in or facilities or controls used for its
manufacture, processing ,packaging, or holding conforms to or are operates or
administered in conformity with current GMP.”

7. Role of GMP with respect to Quality
Management .
To provide the better control on the manufacturing practices different QMS plan,
i.e. Quality Management Systems, are get introduces, which are as follows:
• Preparation of a effective operating procedure, i.e. An effective SOP for all the
activities governing in the facilities.
• By taking proper Change control, Incidences, Deviations, with proper
investigation report.

8. Role of GMP with respect to Personnel:
• Subpart B : Organization and personnel
• Every person involve in the manufacturing process, packaging, or holding of
the drug products must have education, training and proper experience to
perform the activity in a proper and defined manner.
• Every employee should have a GMP training at least once in a year and also at
the time of induction only.
• Proper strength of qualified persons should be there.
• Proper Visit and Guidance of Consultant should be preferred.
• Personnel responsibilities :
1. Should wear clean clothing, also should take daily bath and shave.
2. Personnel shall practice good sanitization and health habits.
3. Access control should be there in controlled areas.
4. If you are ill or not healthy, please take leave and come after complete fitness.

10. Subpart C- Building and facilities
Design and construction features:
• Building should be of suitable size, construction location to facilitate cleaning,
maintenance, and proper operation.
• Space for all the equipment's , instruments and also for storage of Raw material , in
process material and finished products.
• Movement of component should be controlled to avoid contamination.
Storage of release components, drug products containers, closures, and labelling.
Holding of reject material and to be store them in lock and key.
Storage of in process material.
Manufacturing and processing operation.
Packaging and labelling.
Quarantine storage before release of drug products.
Storage of drug products after release.

11. Aseptic processing:
Floor, walls, and ceilings of smooth and hard surface that is easily cleanable like epoxy
coating on floors.
By avoiding corners and edges inside facility by doing cooing of corners.
Temperature and humidity control by installing BMS (Bio maintenance system) and by
AHU (Air handling Units).
By using HEPA filters under positive pressure.
Adequate lighting should be provides in all areas.
Heating, ventilation, and air conditioning (HVAC).
Plumbing.
Sewage and Sanitization.

12. Subpart D: Equipment
Equipment should be appropriate design, adequate size, and suitably located to facilitate operation
for its intended use and for cleaning and maintenance.
Equipment should be constructed with such a material that does not contaminate the material in
touch and also should be inert in nature, should be corrosion free. Mainly stainless steel of desired
grade is prefer, like SS 306 and SS 324 L (Used mainly in parental preparation manufacturing).
Equipment should be designed in such a way that’s its cleaning should be conducted easily , also
proper sanitization schedule should be there for every equipment and instrument.
Calibration Schedule should be there at proper interval and also preventive maintenance.
For those equipment which are software controlled or computer controlled there should be a
routinely calibration, inspection or checking program, with respect to the SOP should be governed.
Proper Installation and validation of equipment should be performed and documented.

13. Subpart F : Production and process control
Written procedures and procedure deviations.
Preparation of master formula record.
To follow the SOP during all process.
Proper flow in of material by FIFO mechanism.
Dispensing
Shifting.
Sampling and testing of in-process material and drug products
Proper equipment identification
Control of microbial contamination.
Reprocessing.

14. Subpart G: Packaging and Labelling control
Material examination and usage criteria: Testing , issuance , handling,
sampling, examination and approval.
Proper Issuance control.
Execution of proper Batch packaging records
Tamper evident packaging requirement for OTC human drug products.
Proper Labelling.
Proper container and closure selection.
Drug product inspection.
Expiration dating.

15. Quality Control ( Subpart I: Laboratory Control)
Responsibilities of quality control unit :
The QC unit must be given responsibility and authority to approve or reject all components, drug
products containers, closures, process material , Packaging material, labelling and drug products.
And the authority to review production records.
Adequate laboratory facilities for testing and approval or rejection of the above listed materials
must be available.
Establishment of scientifically sound and appropriate specification, standard procedures, sampling
plans, test procedures designed to assure that the material conforms to appropriate standards.
Testing and release for distribution.
Stability testing
Reserve samples.
Animals used in testing components.