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GOOD DOCUMENTATION PRACTICES (GDP)
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2018-11-26 | 조회수 | 6,271 |
| 원문 | 한국보건산업진흥원 | ||
| 출처 | |||
GOOD DOCUMENTATION PRACTICES (GDP)
INTRODUCTION
It has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen”, therefore, in the pharmaceutical and medical device industry, we document to provide written proof that something happened. For this reason good documentation practices—commonly referred to as GDPs--are critical.
In addition to regulatory requirements, it is also very important to maintain accurate records for business reasons. By maintaining clear, accurate and timely records you can take a critical look at various processes related to product manufacture with the intent of making quality, product or cost saving improvements. GDPs apply to everyone who documents activities related to cGMP or current Good Manufacturing Practices. GDPs are enforced by regulatory agencies such as the FDA, TGA, EMEA, Health Canada or WHO.
THE BASICS OF GDPs
To meet industry standards, it is critical that all documentation follows GDP when it affects:
GMP processes
material or product identity, quality, purity, strength and safety
The validated state of GMP product manufacture, facilities, equipment, computer systems and testing methods.
It is recommended that your company has a policy or procedure outlining the expected GDP standards, particularly for those requirements that may be unique to your company – for example, using a specific pen color or when and how to use scanned documents/records as original data.
WHAT ARE GOOD DOCUMENTATION PRACTICES?
Good Documentation Practices (GDPs) are the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner.
A key to Good Documentation Practices is to consider these questions each time you record your raw data:
- Is it true? Is it accurate? Is it timely? Is it legible?
Here is a list of some types of documents that require following Good Documentation Practices:
• Analytical Methods, Batch Records, Bills of Materials (BOMs), Certificate of Analyses (CoA), Laboratory Notebooks, Logbooks, Protocols, Quality Records, CAPAs, Internal Inspection Reports, Change Control, Standard Operating Procedures, Training Documentation, and Validation Documents (IQs, OQs and PQs).
GENERAL REQUIREMENTS
The following requirements should be applied to all documentation within the GMP environment:
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General elements |
GDP requirements |
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Clearly written documentation |
All documents must be accurate and written in a manner that prevents errors and ensures consistency. If documents are to be used together, e.g. an SOP and a form, then each should reference the other. Ensure there is traceability between two or more documents/records using formal document numbers or record identification. |
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Using indelible ink |
All records must be filled out in indelible ink for long term legibility. Do not use pencil or ink that can be erased. Color should be specified by the company GDP procedure; often this is limited to blue or black because historically copy/scanning technology was limited in reproduction quality. However, this is less of a factor with the advent of high resolution scanners and color copiers. Consistent use of blue and black ink on GMP documentation provides a more professional perception of your organization. |
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Legible handwritten entries |
A document is unusable if it cannot be read, so care must be taken to ensure that handwriting is legible. All entries must be made at the time the tasks are performed and should be legibly signed and dated. The same is true of electronic documents and records – language should be clear and unambiguous. |
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Reviewing and approving |
Documents and records should be reviewed by someone who did not perform the task to ensure that the information is correct and accurate. A signature and date by the reviewer/approver confirms that a review has taken place. Unsigned documents or records are incomplete and should not be used to perform any task or considered as evidence of a completed task. |
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Staff signatures |
Handwritten signatures must be unique to the individual and listed within the site signature register to ensure that the signature is traceable to a member of staff (or contractor). Staff is not permitted to sign for another member of staff unless delegated. Signatures must never be forged. The management of the signature record should be governed by a procedure and routinely reviewed so that it remains current – new staff should sign the signature register during induction, the signature register must indicate the date staff exit the company. Electronic signatures must meet the same general documentation requirements – refer to EU Annex 11: Computerized Systems or PIC/S Annex 11: Computerized Systems for additional regulatory requirements. |
DOCUMENT CREATION
The creation of documentation can be conceived very much like a process. In doing so, the first stage can be described as event capture. However, the information or event has no status unless it can be verified or approved, which is the second stage. The last part of the process is to communicate the event, in this context by circulating and implementing the document. To illustrate this consider a laboratory test common to many microbiology laboratories - the gram stain technique. To document the procedure, we need to write down the steps which capture the process. As part of a controlled system, the steps need to be verified as being correct and the procedure "signed of" (approval stage). The procedure can then be issued in into routine use along with associated training, which is the communication stage.
DOCUMENT MANAGEMENT
Each pharmaceutical organization should have a system for documentation management. This sets out the rules and mechanisms for creating and controlling a document. GMP makes certain requirements of a documentation system such as:
Assigning responsibility to an individual for control of the system
Ensuring layout, approval, authorization and unique identification of all documents is provided for often by a master documentation SOP
Having a master documentation SOP to include:
Procedures for issue, retrieval, re-issue, maintenance of currency and traceability
Procedures for determining the need for documents
Identification of documents to be included in batch dossiers (for batch release)
Linkage of documents to licenses and regulatory requirements
Outlining audit requirements for the documentation system
Ensuring that only the most up to date version is ever used
Retention times and archiving.
DOCUMENT CONTROL
Further considerations regarding the system controlling documentation include:
Documents should be available at point of use
Masters, including electronic versions, are held under control
There is control over format
There is a system for changes, approval, and re-issue
There is control of documents of an external origin.
The majority of these requirements also make up the elements of the "documentation lifecycle" -- From document creation, through its use, to its storage and archiving, and then to its eventual retirement and possibly replacement by a revised version.
COMPLETING DOCUMENTS AND RECORD-KEEPING
After documents have been designed, prepared, and approved, they must be used and completed properly. For example, where documents require the entry of data, these entries must be made in clear legible handwriting using a suitable indelible medium -- not a pencil. Sufficient space must be provided for entries. With such entries, it is important that any correction made to a document or record must be signed or initialed and dated; the correction must permit the reading of the original information. Where appropriate, the reason for the correction must be recorded.
With record-keeping in general, a record must be kept at the time each action is taken. All activities concerning the conduct of preclinical studies, clinical trials, and the manufacture and control of products must be traceable.
ELECTRONIC RECORDS
The advent of computerized systems caused industry to move away from paper-based systems to paper-less systems. Electronic records offer many advantages. The reality is that typically there is a balance between the two. For example, consider a record for the absence of pathogen test on a non-sterile product. Recording the test result presents us with two options. Firstly it can and often is written on a log sheet. Secondly we can use a laboratory information management system (LIMS) to record the result electronically.
As a controlled form it will be created in Microsoft Word (electronic) and printed onto paper to check it so it can be signed for approval giving it status. This can be done on screen but many people prefer to review a hard copy. Approval can be electronic recording user name and password, or the printed document can be physically signed. In the latter case, the approved document could be scanned so it can be stored, distributed, and referenced electronically. A physically approved document will need photocopying if it is to be distributed in the "paper world." Electronic distribution of a physically signed document can save on paper but does present problems mainly from the scanning process. A scan that creates a picture of the original will be a very large file. Use of optical character recognition in the scanning process produces small files, but the scanning process introduces errors where characters may get missed or replaced requiring a further proof read often from a paper printout. During the active stage, personnel may prefer a hard copy to work from so that an electronic document will be printed onto paper.
Archiving of paper records is costly in terms of Space and to some degree Retrievability, but little more in terms of Maintenance. Archiving of electronic records presents more challenging problems. They only exist as a series of "1's" and "0's" (binary code) on storage media like a CD ROM. With electronic record archiving, the technology window must be understood. This means that the data might be available on the CD, but after 5 years there may not be any hardware that can read it. Essential to electronic record archiving is that companies have an adequate migration strategy. Paper records are still usable after several thousand years but data on discs may be lost after only 5-10 years, or a shorter period if the discs are not properly controlled. The migration strategy should also include the regular transfer of data onto fresh media, even if the hardware has not changed.
The requirements for electronic records and signatures are dealt within the US FDA title 21 part 11 of the Code of Federal Regulations (CFR). Although organizations do not have to use electronic records and signatures, if they do, they must comply with the CFR. It is important that such records are afforded the equivalence to paper records and hand written signatures. The CFR make it clear that procedures shall be followed, records should be documented at the time of performance, and deviations recorded and justified.
DOCUMENT STORAGE
Storage of critical records must at secure place, with access limited to authorized persons. In relation to this, 21CFR 211.180(d) states "…these records or copies…shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph."
The storage location must ensure adequate protection from loss, destruction, or falsification, and from damage due to fire, water, and other disasters. Records which are critical to regulatory compliance or to support essential business activities must be duplicated on paper, microfilm, or electronically, and stored in a separate, secure location in a separate building from the originals.
Data may be recorded by electromagnetic or photographic means, but detailed procedures relating to whatever system is adopted must be available. Accuracy of the record should be checked as per the defined procedure. If documentation is handled by electronic data processing methods, only authorized persons should be able to enter or modify data in the computer, access must be restricted by passwords or other means, and entry of critical data must be independently verified.
If electronic, photographic or other data processing systems are used for the retention of documents, an appropriate storage for required duration is necessary to protect against loss or damage. It is particularly important that during the period of retention, the data can be rendered retrievable and legible within an appropriate period of time. This means having a validated system of data recall. The data should also be available in a legible form. Rapid retrieval of reports and data is essential for audits.
CONCLUSION
Good Documentation Practices are an essential part of cGMP and compliance. When implemented, it will help in maintaining control and ensuring compliance in a cGMP environment.
MAHMOUD AL QAWASMEH
Executive Consultant / GMP & RA – MENA Region
KHIDI
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