21 CFR Part 211

21 CFR Part 211


21 CFR Part 211 Introduction.

21 CFR Part 211 compliance requires the manager of any regulatory controlled manufacturing company to manufacture all medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this 21 CFR Part 211 compliance is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors.

Quality & Risk Embodiment

To achieve 21 CFR Part 211 compliance there must be a comprehensively designed and correctly implemented system of compliance with cGMP rules and regulations.

To achieve 21 CFR Part 211 compliance there must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the manager of the manufacturing authorization and for the authorized person(s).  The basic concepts of Quality Assurance, Good Manufacturing Practice as legislated for in 21 CFR Part 211, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasis their relationships and their fundamental importance to the production and control of medicinal products. 


Quality Assurance

There is a procedure in 21 CFR Part 211 for self-inspection and/or quality audit. Records must show frequent audits for compliance.

Quality Assurance; as detailed in 21 CFR Part 211, is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum and total of the organized arrangements made with the objective of ensuring that medicinal products are compliant with the requirements detailed in Part 211. Quality Assurance therefore incorporates Good Manufacturing Practice (GMP) plus other factors outside the scope of this Guide.

The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that:

  1. Medicinal products are designed and developed in structured document way.
  2. Account of the requirements of Good Manufacturing Practice is made ;
  3. Production and control operations are clearly specified and 21 CFR Part 211, Good Manufacturing Practice adopted;
  4. Managerial responsibilities are clearly specified;
  5. Arrangements are made for the manufacture, supply and verification of the status of all starting and packaging materials;
  6. All necessary controls on intermediate products, and any other in process controls and validations are carried out;
  7. The finished product is correctly processed and checked, according to the defined procedures;
  8. Medicinal products are not sold or supplied before an authorized person has certified that each production batch has been produced & iaw the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicinal products IAW 21 CFR Part 211 legislation.
  9. Satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life;
  10. There is a procedure in 21 CFR Part 211 for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system.

21 CFR Part 211 General Requirements.

GMP relevant Documents must be approved, signed and dated by appropriate and authorized persons.

Specifications describe in detail the  21 CFR Part 211 requirements, with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Manufacturing Formula, Processing and Packaging Instructions state all the starting materials used and lay down all processing and packaging operations. Procedures give directions for performing certain operations e.g. cleaning, clothing, environmental control, sampling, testing, equipment operations, as detailed in 21 CFR Part 211. Records provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent for the quality of the final product.

Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing and marketing authorization dossiers as detailed in 21 CFR Part 211.

GMP relevant Documents should be approved, signed and dated by appropriate and authorized persons.

In accordance with 21 CFR Part 211 documents should have unambiguous contents; title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.

Documents should be regularly reviewed and kept up-to-date. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents. As detailed in Part 11 and Part 211.

Documents should not be hand-written; although, where documents require the entry of data, these entries may be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries.

Any alteration made to the entry on a document should be signed and dated; as per requirements in 21 CFR Part 211, the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded. The records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable. They should be retained for at least one year after the expiry date of the finished product.

Data; in accordance with 21 CFR Part 211 legislation may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data processing methods, only authorized persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked. Batch records electronically stored should be protected by back-up transfer on magnetic tape, microfilm, paper or other means. It is particularly important that the data made available by 21 CFR Part 211 is readily available throughout the period of retention.


21 CFR Part 211



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.



Validation Documentation Matrix (Issue 6.) -- $29.00

This matrix gives a clear and concise overview of all spreadsheets in company use.  It indicates the current validation documentation status and the individual spreadsheet issue levels.  This matrix is a regulatory required document; as per 21 CFR Part 211.

Quantity