Source: https://www.validation-online.net/21-211.html
Timestamp: 2018-01-21 08:48:23
Document Index: 359226439

Matched Legal Cases: ['art 211', 'art 211', 'art 211', 'art 11', 'art 211', 'art 11', 'art 11']

21 211, Validation Documentation | FDA | EU | WHO | Pharma | Med-Dev | Bio-
21 211.
21 211 Introduction.
21 211 or 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 21 211 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.
To achieve 21 211 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, 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, safety, and effectiveness must be designed and built into the product
Quality cannot be inspected or tested into the finished product:
Quality Assurance 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 21 211. Quality Assurance therefore incorporates Good Manufacturing Practice (GMP) plus other factors outside the scope of this Guide.
Medicinal products are designed and developed in structured document way.
Account of the requirements of Good Manufacturing Practice is made ;
Arrangements are made for the manufacture, supply and verification of the status of all starting and packaging materials;
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;
There is a procedure for self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system.
21 211 General Requirements.
Specifications describe in detail the 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.
Documents should be approved, signed and dated by appropriate and authorized persons.
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 21 CFR 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; 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 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 are readily available throughout the period of retention.
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SOP for Equipment Validation (Issue 6.) -- $22.00
SOP for Spreadsheet Creation. -- $125.00
Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
After numerous request for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.
SOP for cGMP Review (Issue 3.) -- $89.00
It is good housekeeping practice for department heads to instigate periodic cGMP walk rounds to analyse, document and ascertain if every-day wear and tear to the fabric of the facility, is compromising the validated status of the facility.
SOP for a SOP (Issue 3.) -- $89.00
The ever sought after SOP for writing an SOP. Adopting a standard format throughout a company for the easy authoring of SOP's is of immense benefit to everyone that has to use them. Our format follows our standard company developed format of a generic template prefixed by an SOP. Follow the SOP and you quickly and simply produce a sound compliant SOP document. In this case the generic SOP template is prefixed by a SOP.
Compendium of Predicate Rules (Issue 3.) -- $85.00
The purpose of producing this document in such a concise manner, is to give a desk top reference document that can be used by authors, engineers and quality staff. It can be used in meetings, during general conversation and during telephone conversations. You first check the CPR to see what rules apply, then check out the rules in depth. You can always be sure that your documents are referenced to the correct GMP requirement.
21 CFR Part 11, Verification (Issue 3.) -- $26.00
Corporate Manual Quality
The FDA has raised the bar. The rationale for change, the approach it has taken and the progress achieved are not as good as some think. In September 2003, The Wall Street Journal published an article informing all that pharmaceutical “manufacturing techniques lag behind those of potato-chip and laundry-soap makers.” The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were not being achieved.
Since then, the FDA, and the industry have been actively, working together to shape the new quality requirements and standards. Compliance now requires a quality systems approach starting with “quality by design” in development and ending with scientific process control in manufacturing. So today, products are more complex; cash is scarcer; and quality requirements require more fundamental understanding. Pharmaceutical companies need to take action on each of these issues in a comprehensive manner.
The Corporate Quality Manual (CQM)is only available on DVD and is normally dispatched within two working days.
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