Skip to main content

US-FDA GUIDELINES (21 CFR)

21 Code of Federal RegulationsParts 210 and 211

Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Part 211 - CURRENTGOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS



Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL


210.1 Status of current good manufacturing practice regulations.

210.2 Applicability of current good manufacturing practice regulations.

210.3 Definitions.

AUTHORITY: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374).

SOURCE: 43 FR 45076, Sept. 29, 1978, unless otherwise noted.

PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS


211.1 Scope
211.3 Definitions


211.22 Responsibilities of quality control unit.
211.25 Personnel Qualifications.
211.28 Personnel responsibilities.
211.34 Consultants.


211.42 Design and construction features.
211.44 Lighting.
211.46 Ventilation, air filtration, air heating and cooling.
211.48 Plumbing.
211.50 Sewage and refuse.
211.52 Washing and toilet facilities.
211.56 Sanitation.
211.58 Maintenance


211.63 Equipment design, size, and location
211.65 Equipment construction.
211.67 Equipment cleaning and maintenance.
211.68 Automatic, mechanical, and electronic equipment.
211.72 Filters.


211.80 General requirements.
211.82 Receipt and storage of untested components, drug product containers, and closures.
211.84 Testing and approval or rejection of components, drug product containers, and closures.
211.86 Use of approved components, drug product containers, and closures.
211.87 Retesting of approved components, drug product containers and closures.
211.89 Rejected components, drug product containers, and closures.
211.94 Drug product containers and closures


211.100 Written procedures; deviations.
211.101 Charge-in of components.
211.103 Calculation of yield.
211.105 Equipment identification.
211.110 Sampling and testing of in-process materials and drug products.
211.111 Time limitations on production.
211.113 Control of microbiological contamination.
211.115 Reprocessing.


211.122 Materials examination and usage criteria.
211.125 Labeling issuance.
211.130 Packaging and labeling operations.
211.132 Tamper-resistant packaging requirements for over-the-counter human drug products.
211.134 Drug product inspection.
211.137 Expiration dating.


211.142 Warehousing procedures.
211.150 Distribution procedures.


211.160 General requirements.
211.165 Testing and release for distribution.
211.166 Stability testing.
211.167 Special testing requirements.
211.170 Reserve samples.
211.173 Laboratory animals.
211.176 Penicillin contamination.


211.180 General requirements.
211.182 Equipment cleaning and use log.
211.184 Component, drug product container, closure, and labeling records.
211.186 Master production and control records.
211.188 Batch production and control records.
211.192 Production record review.
211.194 Laboratory records.
211.196 Distribution records.
211.198 Complaint files.


211.204 Returned drug products.
211.208 Drug product salvaging.



For more information please contact to tradharaman86@gmail.com

Comments

Post a Comment

Popular posts from this blog

DATA INTEGRITY (ALCOA ++)

 INTRODUCTION   The purpose of this guidance is to clarify the role of data integrity in current good manufacturing  practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers  Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of  Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished  Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron  Emission Tomography Drugs. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. FDA expects that data be reliable and accurate (see the “Background” section). CGMP  regulations and guidance allow for flexible and risk-based strategies to prevent and detect data  integrity issues. Firms should implement meaningful and effective strategies to manage their data  integrity risks based upon their process understanding and knowledge management of tec
Post a Comment
Read more

PERMITTED DAILY EXPOSURE (PDE)

PERMITTED DAILY EXPOSURE (PDE) or ACCEPTANCE DAILY EXPOSURE Introduction During the manufacture of medicinal products accidental cross contamination can result from the uncontrolled release of dust, gases, vapours, aerosols, genetic material or organisms from active substances, other starting materials, and other products being processed concurrently, as well as from residues on equipment, and from operators ’ clothing. Due to the perceived risk, certain classes of medicinal product have previously been required to be manufactured in dedicated or segregated self contained facilities including, “certain antibiotics, certain hormones, certain cytotoxics and certain highly active drugs”. Until now no official guidance is available in order to assist manufacturers to differentiate between individual products within these specified classes. METHODS FOR ESTABLISHING EXPOSURE LIMITS The Gaylor-Kodell method of risk assessment (Gaylor, D. W. and Kodell, R. L.: Linea
Post a Comment
Read more

21 Code of Federal Regulations Parts 211 Subpart K-Returned and Salvaged Drug Products

21 Code of Federal Regulations Parts 211 Subpart K-Returned and Salvaged Drug Products § 211.204 Returned drug products. Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality or purity of the drug product, the returned drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics. Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or co
Post a Comment
Read more