Title 21 in the federal regulations are regulations which regulates the Food and Drugs in United States of America. Part 11 within this Code of Federal Regulations is related to US Food and Drug Administration (FDA) guidelines about electronic records and electronic signatures.
The regulations in this part set forth the criteria under which the US FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 21 cfr Part 11 became effective in August 1997
21 CFR Part 11, states the requirements for procedures for creating, modifying, maintaining, archiving, retrieving, and transmitting electronic records and electronic signatures by virtue of which they can be considered or rendered to be trustworthy, reliable and equivalent to paper records.
CFR 21 Part 11 requires that a drug manufacturer ,medical device manufacturer and biologics developers and all other industries regulated by FDA to implement controls for their electronic system, like audits, documentation for software , system validations, audit trails, electronic signatures, and for systems which are handling the electronic data which is required to be maintained by the FDA predicate rules or the systems which process data used for demonstration of compliance of a requirement or a rule.
CFR21 part 11 also applies to the electronic submissions made to FDA like ANDA, NDA.
Many drug manufacturers and felt that the 21CFR11 is bit difficult to implement in the way it is desired in the regulations and US FDA has listed the points why they gave relaxations at some points of implementation in CFR 21 part 11 are as follows.
1.Unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule.
2.Significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted.
3.Discourage innovation and technological advances without providing a significant public health benefit.
In an effort towards proper implementation US FDA released a guidance document in August of 2003 the
US FDA published the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance which describes how US FDA intends to exercise enforcement discretion and sets forth the following considerations related to Part 11:
US FDA has made an announcement on 8-july-2010 with respect to implementation of cfr 21 part 11 as follows
The US (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.
1. CFR 21 Part 11 remains in effect since the issuance of the guidance and the exercise of enforcement discretion applies as identified in the guidance.
2.The guidance sets out certain conditions related to the validation, audit trail, record retention, record copying, and legacy systems where the US FDA says they do not intend to take enforcement action to enforce compliance. also FDA mentions that 'Conversely, violations of CFR 21 part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation'.
3.Records must also be maintained or submitted in accordance with regulatory requirements outside of Part 11, and we will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.
Only part so far routinely enforced is access control, where as 21CFR11 the "predicate rules" which required the records to be kept in the first place are still in effect. If electronic records are illegible, inaccessible, or corrupted the manufacturers are still subject to those requirements.
Paper documents are still considered if a pharma company keeps "hard copies" of all mandatory records, for regulatory purpose the paper documents are also considered as authoritative documents.
A drug manufacturer is required to make a claim very carefully about the "hard copies" of mandatory records are authoritative document. Hence to the "hard copy should be an accurate and complete copy of its electronic source and can be used for regulatory purposes.
US FDA is expected to begin conducting the CFR 21 Part 11 focused inspections soon.
Also see CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines
What is High-Efficiency Particulate Air HEPA Filter
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
You may also like following articles
What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
Quality by design concept for pharmaceutical industry
Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals