INTRODUCTION:

The GDP can be defined as “Good documentation practice is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. Good Documentation Practices (GDP) are methods for recording, correcting and managing data, documents and records, to ensure the reliability and integrity of information and data throughout all aspects of a product's lifecycle. Clearly written documents prevent errors of various activities in pharma each and every activity is written in specific documents such as SOPs and strictly followed. Verbal communications may be the create errors and there was no proof. So, to minimize error by good document practice that all important documents such as Master formula record, procedure and record must be free from errors and documented.

1. Type of formulation

2. Country requirements

3. Availability of ERP or SAP system.¹

The U.S. Food and Drug Administration (FDA) Set Some GDP Standards, others fall under the Current Good Manufacturing Practice (CGMP). All pharmaceutical, bioscience and healthcare companies, as well as their vendor partners, must observe GDP or face warnings or penalties levied by the FDA. According to the World Health Organization (WHO), The purposes of GDP are:

1. To define the specifications and procedures for all materials and methods of manufacture and control.

2. To ensure that all personnel concerned with manufacturing know what to do and when to do it.

3. To ensure that authorized persons have all the information necessary to decide whether or not to release A batch of A drug For Sale.

4. To ensure the existence of documented evidence, traceability and to provide records and an audit trail that will permit investigation.

5. To ensure the availability of the data needed for validation, review and statistical analysis.

Documentation is also key to GMP compliance for it ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product (3). For example, with the FDA Code of Federal Regulations (CFR), 21CFR 211.180(e), records and reports, states: “written records…shall be maintained so that data therein can be used for evaluating…the quality standards of each drug product…”. This extract thereby links the importance of good documentation to GMP. This paper presents an overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors. Specific topics for discussion include the following:

1. Good manufacturing practice and documentation including errors and error correction

2. Document fundamentals

3. Document creation

4. Document management

5. Types of documents

6. Best practices for document creation, including style and layout

7. Completing documents and record-keeping

8. Electronic records

9. Document storage ²

Objectives:

1. Establish, control, monitor and record all activities, which directly or indirectly impact on all aspects of the quality of medicinal products.

2. Appropriate good documentation practice should be applied with respect to the type of document

3. Ensure that the document should maintained accuracy, integrity, availability and legibility during the document life cycle.

4. Document should be free from error and during any point of if error identify then rectify with proper reason for correcting including sign and date.

5. The Term “Written” in any document means recorded/document on media from which data may be rendered in a human readable form.

6. Site Master File: A document describing the GMP related activities of the manufacturer.³

Importance of Documentations:

As per GMP documentation control “If it not written down, then it did not happen” The document provides information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be. 4

Scope:

The Good documentation practices are target to both paper as well as electronic data or manually filled records or generated electronically in a GDP environment.⁵

Basics of Documentations:

To meet industry standards, it is critical that all documentation follows GDP when it affects:

1. GMP processes

2. Material or product identity, quality, purity, strength and safety

3. 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. ⁶

Purposes:

1. To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc.

2. To define the specifications and procedures for all materials and methods of manufacture and control.

3. To ensure the existence of documented evidence, traceability and to provide records and an audit trail that will permit investigation.

4. Ensures availability of data for validation, review and statistical analysis.

5. To ensure that all personnel concerned with manufacturing know what to do and when to do it.

6. To improve performance.

7. Regulatory requirements. ⁷

Key Quality and Regulated Documents:

1. Concise:

Present information clearly so it can be easily understood with no room for misinterpretation. For example, the date format “05/06/12” can cause confusion. Use one that is unambiguous, such as “05 Jun 2012.”

2. Legible:

Information should be readable and leave no room for error (for example, hand-written data that are not legible may cloud data analysis or result in “Missing Data”).

3. Accurate:

Documentation should be error-free―properly reviewed, verified and approved. Information should be recorded as an event happens and not after the fact, so as to avoid recording “What You Remember” rather than “What Actually Happened.”

4. Traceable:

Documentation should be traceable. make it clear who logged the information, what it was, and when and why it was documented.

Do’s and Don’ts with Document:

1. Use black or blue permanent, indelible ink.

2. Make clear, complete and legible entries.

3. Make an entry when an event happens (Not Later).

4. Make corrections that are legible and traceable. for example, when a correction is required, put a line through the error, make the correction next to the error, include an explanation (If it is not self-explanatory), and initial and date the correction.

5. If it is not appropriate to fill in a space in a document (Such as an empty page), enter “N/A,” your initials and the date so that no further information can be added later.

6. Follow established standard operating procedures (Sops)―for example, document review and approval processes, version control, and date and time formats, as well as record retention, change control, electronic signature (If applicable) and so on.

7. Provide training to everyone in company.

8. Do not use pencils or erasable ink.

9. Do not use “Write-Out” or any masking devices.

10. Do not make corrections that are not traceable (For example, overwriting entries with no date, initial or explanation).

11. Do not use “Sticky” notes.

12. Do not back-date or post-date.

13. Do not use ditto marks.

14. Do not use asterisks that may cause confusion (Such as using the same asterisk for different footnotes).

15. Do not transcribe data.

16. Do not use unbound laboratory notebooks without page numbers (That is, avoid any doubt concerning missing pages).⁸

Types of Documentations:

Documentation refers to both printed forms and electronic systems. Broadly speaking, documentation types can be classified as:

1. Specifications

2. Manufacturing and packaging instructions

3. Standard operating procedures

4. Records.

More specifically, the various types of documents found within a typical pharmaceutical organization include:

1. Technical agreements

2. Confidentiality agreements

3. Technical reports

4. Quality system related documents

5. Quality Manual

6. SOP’s

7. Validation protocols and reports

8. Deviation reports

9. Audit plans

10. Validation master Plans and validation documents including URS, DQ, FAT, IQ, OQ, PQ, and validation reports

11. Test material related documents including product specification, test material receipt, and reports

12. Personnel related documents including training records

13. Facility related documents including floor plans, HVAC plans, and environmental specifications

14. Deviation forms including unplanned deviations and system failure investigation

15. Change control

16. Worksheets, notebooks, and logbooks documentation must be clear, free from errors, subject to regular review, and be kept up-to date.⁹

MATERIALS AND METHODS:

Constituents of Good Documentation:

· Approve, review and update documents

· Changes and current revision status of documents identified

· Relevant versions of applicable documents available at points of use

· Documents remain legible and readily identifiable

· Documents of external origin identified, and their distribution controlled

· Prevent unintended use of obsolete documents, and archiving

Principle:

Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer's Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. The main objective of the system of documentation utilized must be to establish, control, monitor and record all activities which directly or indirectly impact on all aspects of the quality of medicinal products. The Quality Management System should include sufficient instructional detail to facilitate a common understanding of the requirements, in addition to providing for sufficient recording of the various processes and evaluation of any observations, so that ongoing application of the requirements may be demonstrated. There are two primary types of documentation used to manage and record GMP compliance: instructions (directions, requirements) and records/reports. Appropriate good documentation practice should be applied with respect to the type of document. Suitable controls should be implemented to ensure the accuracy, integrity, availability and legibility of documents. Instruction documents should be free from errors and available in writing. The term ‘written’ means recorded, or documented on media from which data may be rendered in a human readable form. ¹⁰

Documentations Challenges:

Because of the complexities of record keeping in the pharmaceutical industry, there are inherent challenges that companies face in regard to GDP. Some of the most common concerns compliance officers must keep in mind include:

1. Lack of proper record-keeping when documents are transferred from one department or facility to another.

2. Critical oversight regarding document issue, data collection and document review.

3. Consistent labeling which includes identification codes, document revision codes, product identification codes and product lot numbers. ^[11]

Documents Errors:

Common documentation errors that commonly appear in FDA warning letters and reports from other regulatory authorities include:

1. Documentation not contemporaneous

2. Use of ditto marks

3. Use of signature stamp

4. Failure to use ink as specified by procedure

5. Incorrect ink used for entries causing illegible data when a substance was spilled

6. Logbook corrections failed to identify person who made the changes

7. Obscured original data

8. Use of pencil

9. Inaccurate records

10. Sample sequence table and audit trail not documented (to draw on the commonly used phrase: “if it is not documented, it didn’t happen”)

11. Handwritten changes not dated

12. Write-overs, multiple line-through, and use of "white-out" or other masking device. the most common GMP citation occurs with correction of errors when information is recorded. Correction of documentation errors should include:

A. Draw a single line through the error,

B. Make the correction next to the error,

C. Write an explanation for the error,

D. Sign and date the correction.

E. It is recommended that these common errors are highlighted in training on the creation and use of documentation.¹²

Documents Fundamentals:

There are many different types of documents found within pharmaceutical organizations, each serving a different purpose. Although there are different document types, documents can generally be placed into a small number of categories cascading down the quality system. With the types of documents and some of the errors relating to documentation use, it is useful to consider at this point how documents come together and what the basics of a document are. This is illustrated in Figure 1.

Figure 1. Classic Documentation Hierarchy

The vast majority of documents are procedures or records. The most common examples of a procedure within the pharmaceutical organization are standard operating procedures (SOP). A record is often related to a specific SOP and carries the confirmatory details required of that SOP. For example, the SOP for a sterility test record should require details such as the product name, its batch number, and its test result.

Documents 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.

Figure 2. Documentation Flow Path

Documents Control:

Further considerations regarding the system controlling documentation include:

1. Documents should be available at point of use

2. Masters, including electronic versions, are held under control

3. There is control over format

4. There is a system for changes, approval, and re-issue

5. 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. The control of documents necessitates the following steps:

Documents Approval:

Documents must be approved for use. They must be approved, signed, and dated by appropriate authorized personnel.

Handwritten Entries:

1. Adequate space needs to be provided for expected handwritten entries

2. Handwritten entries must be in indelible ink

3. Critical entries must be independently checked (second person verified)

4. No spaces for handwritten entries should be left blank. If unused, they are crossed out or "n/a" (or similar text) entered

5. Ditto marks or continuation lines are not acceptable

6. A stamp in lieu of a handwritten signature is not acceptable.

Documents Copies:

1. Copies need to be clear and legible

2. Errors must not be introduced

3. Documents should be regularly reviewed and kept current,

4. Documents should be retained and readily available for audits

5. Archived documents must be retrievable for the appropriate duration

6. Electronic document management systems must be validated

7. Electronic records must be backed up.

Documents Modification:

1. Handwritten modifications are signed and dated

2. Altered text should not be obscured (e.g., no obliterating the text through crossing- out)

3. Where appropriate, the reason for alteration must be noted (for example, "error." is a common abbreviated reason, indicating "entry error"),

4. Controls exist to prevent the inadvertent use of superseded documents

5. Electronic versions should only be modified by authorized personnel

6. Access to electronic documents must be controlled by password or other means.

A history (audit trail) must be maintained of changes and deletions to electronic documents. Well-designed documentation and appropriate documentation are paramount. It is necessary to document every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and could be considered to be adulterated.¹³

Document Style and Layout:

It is often helpful to adopt a specific document style for consistency of operations. Elements of the style should be specified in an approved procedure. These might include (9):

· Logo

· Pagination/ layout to prevent confusion and ensure the document is kept in order

· Headers and footers

· Font including the size is useful to minimize errors introduced when changing between fonts

· Page numbers

· Executive summary

· Changes - Change control is important for traceability

· Circulation list - to ensure the document is reviewed and received by the appropriate personnel

· Table of contents

· Authorization levels stated on document

· Cross references

· Revision history

· Definitions

· Content (context and meaning)

· A clear area for recording problems/ incidents

· Use of pictures, flow charts, diagrams as suitable alternatives to text.

Care should be taken in designing and stylizing documentation. Documents must have unambiguous contents. The title, nature, and purpose should be clearly stated. They must be laid out in an orderly fashion. Documents must be easy to check. Reproduced documents must be clear and legible. Many people do not consider the importance of how key information is presented within a document. This can result in the reader wasting time or not conducting the correct tasks. For example, a poorly structured document could ask the user to conduct a task that requires some action to be performed prior to the subject task – but only mentions the prework at the end of the document and with no reference to the pre-work at the beginning. Helpful considerations for layouts include the following:

· Cover page with identifiers and status

· Table of contents – creating a road map through the document

· Scope and applicability section

· Introduction

· Information and instructions in a logical sequence

· Additional information and detail.

Numerical information must include the correct use of units. The use of color coding in graphical information, such as black lines for existing pipework and red lines for new pipework, might also be useful. The narrative must consider writing style, nomenclature, and dealing with errors and corrections It is useful to consider different styles to accommodate the different reading styles of readers. There are thought to be three styles based on the linguistic, logical and spatial talents. These can be summarized as (10):

· Linguistic talent. There is a strong ability to write and talk fluently. Phrases like “gift of the gab” often apply. Individuals in this category can also write and read well. Shakespeare had linguistic talent.

· Logical talent. There is strong ability to think logically and are quick in calculating odds and statistics. Albert Einstein had logic talent.

· Spatial talent. There is strong ability to image things in the “mind’s eye.” These people often have good navigational skills such as Christopher Columbus. The following should be considered whenever possible:

· Narrative – written text

· Tabular – tables

· Charts – bar charts, pie charts

· Color – bold – underlined text

· Pictures – photographs, images

· Diagrams – 2d,3d

· Process logic – flowcharts

Including various combinations of the above is extremely useful. A flow chart might help with navigating the document while pictures are very useful in dressing procedures for entry into cleanrooms.¹⁴

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.¹⁵

Documents 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 of document 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. 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.¹⁶

CONCLUSION:

From the above review we are concluded that good documentation practices are a need of pharmaceutical industry. documentation is essential to achieve total approach towards GMP. The goal of good documentation practices is defined manufactures of system information. Documentation also serves as existence of evidence and allows traceability.

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Received on 14.07.2021 Modified on 29.07.2021

Asian J. Research Chem. 2021; 14(5):368-374.

DOI: 10.52711/0974-4150.2021.00063