cGMP AS PER USFDA

Here is detail matter about Current good manufacturing practices as per USFDA

1. CGMP as per USFDA
(CURRENT GOOD MANUFACUTURING PRACTICE as
per UNITED STATES FOOD DRUG ADMINISTRATION)






PRESENTED BY
S.THAARANI (20CQ1S0705)
M PHARMACY
DEPT OF PHARMACEUTIAL ANALYSIS
SEVEN HILLS COLLEGE OF PHARMACY

2. USFDA GUIDELINES (including CDER & CBER)
USFDA - United States of food and drug administration
CDER - Centre for doing evaluation and research ·
CBER - Centre for biologics evaluation and research
USFDA is an agency with department of Health & Human Services and consists of 9 Center - Level
organizations 13 Headquarter (HQ) offices.
USFDA
Office of the commissioner & FDA HQ offices
1. CBER - Center for biologics evaluation & research.
2. CDRH - Center for Devices & radiological health.
3. CDER - Center for drug & evaluation & research.
4. CFSAN - Center for food safety and applied nutrition.
5. CTP - Center for tobacco products.
6. CVM - center for vertiary medicine.
7. NCTR - National Center for toxicological research.
8. Office of regulatory affairs.
9. Office of operations.
U.S.FOOD AND DRUG ADMINISTRATION (USFDA);
USFDA is responsible for protecting public health by ensuring the safety; efficacy and
security of human and veterinary drugs; biological drugs; medical devices by ensuring safety of our
nation’s food supply and cosmetics and products that emits radiation.
Janet Woodcock is commissioner of USFDA (current)
USFDA Founded on 30
th
June 1906, Headquarters Silver Spring Maryland.
CGMP as per USFDA;
FDA ensures quality of drugs products by carefully monitoring drug manufacture’s
compliance with its Current Good Manufacture Practice (CGMP) regulations
The minimal requirements for processes; facilities and controls utilised in manufacture;
processing and packing of a drug product are outlined in CGMP regulation and medicines.
FDA assessors and inspectors from FDA analyse whether the company has necessary
facilities, equipment and ability to manufacture drug to sell in market intended for human use.
Principles of CGMP;
 Design and Construct equipment and facilities properly.
 Follow instructions and written procedures.
 Documents work.

3.  Validate work.
 Equipment and facilities are monitored.
 Write step by step operating procedures and work on instructions.
 Protect against contamination.
 Conduct planned and periodic audits.
List of Important Documents in CGMP;
 Policies
 SOPs
 Specifications
 Master Formula Record
 Batch Package Record
 Manuals
 Master Plans
 Validation Protocols
 Formats
 Records
USFDA Regulations;
FDA portions of CFR is in title 21 contain requirements for compliance to CGMP.
21 CFR part 210 - CGMP in manufacturing; processing; packing; holding of drugs.
21 CFR part 211 - CGMP for finished pharmaceuticals.
21 CFR part 600 - CGMP for biological products.
21 CFR part 820 - CGMP for medical devices.
Why CGMP’S IMPORTANT:
 A Consumer usually unable to detect the product is safe. While CGMP’S require
testing, testing alone is not adequate to ensure quality.
 FDA will often use these reports to identify sites for which an inspection /
investigation needed.
CGMP’S For Finished Pharmaceutical; Part 211
SUBPART A <-> SUBPART K
Subpart A General Provision
Subpart B Organisation and personnel
Subpart C Building and Facilities
Subpart D Equipment
Subpart E Controls, Components and Drug product Container and Closure
Subpart F Production and Labelling Control
Subpart G Handling and Distribution
Subpart H Laboratory Control

4. Subpart I Records and Control
Subpart J Returned and Salvaged Drugs
SUBPART A - GENERAL PROVISIONS;
211.1 - Scope
 The minimum cgmp for preparation of drug products for administration to humans
/ animals.
 The CGMP (requirement) in this part shall not be enforced for OTC drugs and all
ingredients are marketed ordinarily and consumed as human foods.
211.3 - Definitions
 The Definitions in section 201 is applicable for part 211
SUBPART B - ORGANISATION AND PERSONNEL;
211.22 - Responsibilities and QC unit
The QC unit have responsibility and authority to approve/reject all components; drug
product containers, closures, in process materials, packaging materials; labelling and records.
- Rejecting all above impact the identity, quality and purity of drug product.
211.25 - Personnel Qualification
Each person under industry shall have the education training and experience to provide
assurance to drug product has safety, quality and purity
211.28 - Personnel Responsibilities
Personnel working in manufacturing; processing; packing drugs; holding drug product
shall wear clean clothing’s; good sanitation and good health habits.
211.34 - Consultants
Records should be maintained that stating name; address; qualification of consultants
and service they provide.
SUB PART C - BUILDINGS AND FACILITIES;
211.42 - Design and Construction Features
Buildings should be in suitable size; with good cleaning facilities; maintenance, proper
operative condition.
Adequate space for placing equipment to prevents contamination.

5. 211.44 - Lighting
Adequate light is provided in all areas.
211.46 - Ventilation; Filtration; Air Heating; Cooling
Buildings should be provided with proper ventilation.
Pre filters; HEPA filters are used.
211.48 - Plumbing
Potable water shall be supplied continuously under positive pressure with free of
contaminants.
211.50 - Sewage and Refuse
Sewage; trash from buildings and premises are disposed off in safe and sanitary manner.
211.52 - Washing and Toilet Facilities
211.56 - Sanitations
211.58 - Maintenance
SUB PART D - EQUIPMENT;
211.63 - Design, Size, Location
Equipment should be made of adequate size; Appropriate design and with good cleaning
and maintenance.
211.65 - Equipment Construction
Equipment should be constructed so that surface that contacts with drug components
will not be contaminated.
211.67 - Equipment Cleaning Maintenance
Equipment is cleaned to prevent contamination, cleanliness of the equipment is
inspected before us; Cleaning records should be maintained.
211.68 - Automatic Mechanical Equipment
Computer related equipment should perform satisfactorily.
They should be calibrated routinely; written records of calibration are maintained.
211.72 - Filter
Fibre releasing filter may not be used for injectable drug products; unless it is not
possible to manufacture such drug product without use of fibre releasing filters; use additional non –

6. fibre releasing filters to reduce content of particles in injectable drug product. Use asbestos
containing filter.
SUB PART E - CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES;
211.80 - General Requirement
Written procedures in sufficient manner regarding manufacturing.
211.82 - Receipts and Storage of Untested Components drug products
Non – tested components are stored under quarantine until they have been
tested/examine and released.
211.84 - Testing and Approval / Rejection of Components; drug products
The lot has been sampled; tested; released and used by Quality Control unit.
211.86 - Use of Components, drug product; containers and closure
Products are rotated so the oldest approved stock is used first.
211.87 - Retesting of Approved Components Drug products; containers and closures

SUB PART F - PRODUCTION AND PROCESS CONTROL;
211.100 - Written Procedure
Written procedures are maintained for production and process control to assure quality
and purity of drugs products.
211.103 - Calculation of Yield
Actual yields and percentage theoretical yield is determined during manufacturing;
processing; packing of drugs products.
211.113 - Control of m/o Contamination
Written procedures are designed to prevent m/o contamination of drug products to be
sterile; such procedures need validation.
211.115 - Reprocessing
SUB PART G - PACKING AND LABELLING CONTROL ;
211.122 - Material Examination and Usage Criteria
There should be written procedures that describes the detail receipts ; identification ;
storage ; handling ; sampling ; examination ; labelling ; packing ; materials that do not meet
specifications should be rejected to prevent their use.

7. 211.125 - Labelling Issuance
Labelling materials issued for batch production should be carefully examined for
identifying the master/batch production records.
211.137 - Expiration Dating
It is related to any storage conditions states on labelling as determined by stability
studies.
SUB PART H - HOLDING AND DISTRIBUTION;
211.142 - Warehousing Procedures
Storing of drug products under appropriate condition of temperature; humidity; light
the drug products not get affected.
211.150 - Distribution Procedures
An oldest approved stock of drug products is distributed first.
SUB PART I - LABORATARY CONTROLS;
211.160 - General Requirements
Calibration of instruments apparatus; recording device should be maintained in written
format.
211.165 - Testing and Releasing for Distribution
Sterility /Pyrogen testing is conducted on specific batched of radiopharmaceuticals.
211.166 - Stability Testing
Stability testing should determine appropriate storage and expiry date.
211.173 - Laboratory Animals
Animals used for testing drug products should comply specification.
211.176 - Penicillin Contamination
Non- penicillin drug products exposed to cross- contamination with penicillin; the non-
penicillin drug products should be tested for presence of penicillin.
SUB PART J - RECORDS AND REPORTS;
211.182 - Equipment Cleaning Log
211.184 - Components; drug product; Containers; Closures; Records
211.186 - Master Production and Control Records

8. 211.188 - Batch Production and Control Records
211.192 - Production Records
211.194 - Laboratory Records
211.196 And 211.198 - Distribution; Records; Complaint Files
SUB PART K - RETURNED AND SALVAGED DRUG PRODUCTS;
211.204 - Returned Drug product
Returned drug products are stored and not safe.
211.208 - Drug product Salvaging
Drug products are subjected to proper storage condition like extreme temperature;
humidity; equipment failure not be salvaged and returned to market place.
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER);
CDER’s mission is to protect and promote public health by helping to ensure that drugs
are safe and effective which is intended for human use.
The drug products should be ensured with quality and safety.
CDER as a part of USFDA regulates OTC-over the counter and prescription drugs
including biological therapeutics and generic drugs are safe and effective.
Example : Fluoride tooth paste; Antiperspirants; Dandruff Shampoo; sunscreen’s are all
considered as Drugs.
CURRENT CDER ACTIVITY;
 To overcome new drug development and review of drug marketing.
 To ensure safe use of approved medicines and oversee post marketing drug safety.
 To ensure drug manufacturing and quality.
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER);
CBER as a part of FDA regulates biologics products for human use under applicable
federal laws, including “Public Health Service Act” and “Federal Food Drug and Cosmetics act”.
 CBER protects safe and effective biological products to ensure public health safety.
 CBER provides appropriate information on use of biological products and public.
Examples of Biological Products;
 Vaccines
 Blood products
 Live Biotherapeutics

9.  Gene therapeutics [Monoclonal antibodies and proteins are regulated by FDA
CDER]
 Products derived from human, animal, plants, m/o
ACTIVITY;
 Monitoring pre- clinical and clinical testing of new biological products and
evaluating their safety and effectiveness before marketing.
 Research on vaccines and aids medications.
CBER’S APPROVAL;
In order to approve biological parts in U.S an applicant must need to submit Biologics
License Application (BLA).

10. THANK YOU