INTRODUCTION:

Written, printed, magnetic, or electronic media containing information or data on a product's formulation and manufacturing process are referred to as documents or records. Paperwork must be traceable, written or generated in an easily reading style, and contain adequate details about the event's activities. Records or documentation certify that the goods are produced according to previously established procedures and requirements.

In the quality assurance system, documentation is a crucial element that needs to be utilised in needs of GMP. Every member of the production staff should know what to do and when, and authorised individuals should have access to all the information required to decide whether to make a batch of drugs for sale. Traceability and documented proof should also be guaranteed. Lastly, it is necessary to specify all manufacturing and control material and procedure standards and processes. Because the design and use of the document are based on the information and control system of the manufacturer, this lowers the likelihood of misunderstandings and/or errors in spoken communication. As a result, the quality and consistency of all goods and services are improved by providing clear, clear instructions for people participating in specific activities, including active pharmaceutical substances that are legally required.

Documentation must be linked to all aspects of GMP since it is an essential part of the quality assurance system. It makes an effort to specify the requirements for all materials as well as the manufacturing and control process, ensure that all personnel involved in the manufacturing process have the information necessary to decide whether or not to release a batch of a drug for sale, and provide an audit trail that will enable the history of any suspected defective batch to be investigated. The specifications should go into great detail on the requirements that must be fulfilled by the products or materials used or acquired during manufacturing. They offer a starting point for evaluating quality. Documentation gives auditors a way to evaluate the general standard of operations within a company and the final product.^1-2

Documentation:

Document is any written statement or proof. Documentation is an essential part of Quality assurance and Quality control system and is related to all aspects of Good Manufacturing Practices (GMP). It is mainly defining the specifications for all materials, method of manufacturing and control. It also ensures that the personnel concerned with manufacturing should know information to decide whether to release the batch or not for sale it provides an audit trial which also allows the investigation of history of any suspected defective batch.⁵

Purpose of Documentation:

· Ensures documented evidence, traceability, provide records and audit trail for investigation.

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

· Defines specifications and procedures for all materials and methods of manufacture and control.

· Ensures all personnel know what to do and when to do it.

· Ensure that authorized persons have all information necessary for release of product.⁴

The ‘Documents' Model:

The “DOCUMENTS" model lists out the areas required for GMP documents for implementation:

D - Design, development, deviation, dossiers, and Drug Master Files for regulated markets distribution records.

O - Operational procedures/techniques/methods, out of Specifications (00S). Out of Trend (00T).

C - Cleaning, calibration, controls, complaints, container and closures, contamination, and change control.

U - User requirement specifications, utilities like water systems, HVAC, AHU, etc.

M - Man, materials, machines, methods, maintenance. Manufacturing operations and controls, monitoring, master formula, manuals (quality, safety, and environment), medical records.

E - Engineering control and practices, Environmental Control, Equipment qualification documents.

N - Non-routine activities, new products, and substances.

T-Technology transfer, training, testing. Trend analysis, technical dossiers.

S - SOPs, safety practices, sanitation, storage, self-inspection, standardization, supplier qualification, specifications, standard test procedures, and site master file7.^1,3

General Requirements:

1. Good documentation constitutes an essential part of the quality assurance system.

2. Clearly written procedures prevent errors resulting from spoken communication, and clear documentation permits tracing of activities performed.

3. Documents must be designed, prepared, reviewed, and distributed with care.

4. Documents must be approved, signed, and dated by the appropriate competent and authorized persons.

5. Documents must have unambiguous contents. The title, nature, and purpose should be clearly stated. They must be laid out in an orderly fashion and be easy to check. Reproduced documents must be clear and legible.

6. Documents must be regularly reviewed and kept up-to-date. When a document has been revised, systems must be operated to prevent inadvertent use of superseded document: (e.g., only current documentation should be available for use).

7. Documents must not be handwritten; however, where documents require the entry of date, these entries may be made in clear legible handwriting using a suitable indelible medium (i.e., not a pencil). Sufficient space must be provided for such entries.

8. Any correction made to a document or record must be signed or initialled and dated, the correction must permit the reading of the original information. Where appropriate, the reason for the correction must be recorded.^4,6

Types of Documentation:

There are various types of procedures that a GMP facility follows. Given below is a list of the common types of documents.

1. Quality manual: A global company document that describes, in paragraph form, the regulations and /or parts of the regulations that the company is required to follow.

2. Policies: Documents that describe in general terms, and not with step-by-step instructions, how specific GMP aspects (such as security, documentation, health, and responsibilities) will be implemented.

3. Standard operating procedures (SOPS): Step-by-step instructions for performing operational tasks or activities.

4. Batch records: These documents are typically used and completed by the manufacturing department. Batch records provide step-by-step instructions for production-related tasks and activities, besides including areas on the batch record itself for documenting such tasks.

5. Test methods: These documents are typically used and completed by the quality control (QC) department. Test methods provide step-by-step instructions for testing supplies, materials, products, and other production-related tasks and activities, e.g., environmental monitoring of the GMP facility. Test methods typically contain forms that have to be filled in at the end of the procedure; this is for documenting the testing and the results of the testing.

6. Specifications: Documents that list the requirements that a supply, material, or product must meet before being released for use or sale. The QC department will compare their test results to specifications to determine if they pass the test.

7. Logbooks: Bound collection of forms used to document activities. Typically logbooks are used for documenting the operation, maintenance, and calibration of apiece of equipment. Logbooks are also used to record critical activities, e.g.; monitoring of clean rooms, solution preparation, recording of deviation, change controls and its corrective action assignment.⁸

Quality Documentation Hierarchy:

Fig. 1: Quality documentation hierarchy

· At the top of the hierarchy are the regulations the company must adhere to (e.g., USFDA/EU GMP/ICH/Schedule M), which dictate directives for sublevels.

· Level 1 documents (e.g., Quality Manual) beneath regulations break them down into specific parts relevant to the company's compliance. These documents set out overarching principles and guidelines for developing, documenting, and implementing a compliant quality system applicable to all departments.

· Level 2 documents further detailed regulations on specific subjects or topics (e.g., Company Policies), ensuring consistency across departments by establishing guidelines for subordinate level procedures.

· Level 2 documents offer overall intentions and guidelines for critical programs or systems, without providing specific directive instructions or forms. They apply universally across departments.

· SOPs, the next level, provide detailed step-by-step instructions for operational tasks mentioned in preceding levels (e.g., SOP for Controlled Document Management). Level 3 documents (SOPs) are department or function-specific.

· Finally, level 4 documents are the most specific (e.g., batch records, test methods) and apply to specific departments, products, equipment, or processes. They offer detailed instructions and means for documenting tasks, which may override instructions in higher-level documents. The document hierarchy pyramid offers an organized approach, customizable to the company's needs with more or fewer levels as required.^9,10[Chingale Nilam e tl.2024]

Good Documentation Practices:

Introduction:

The pharmaceutical industry uses the phrase "good documentation practice," or "GDP" or "GDocP," to describe the integrity of data gathering and reporting that supports pharmaceutical product development, registration, commercialisation, and life-cycle management. Following the GDPs guarantees avoiding mistakes in the manufacturing process and when analysing pharmaceutical products, which could otherwise affect patient safety, product quality, the condition of manufacturing facilities, and associated operations. Both US and European regulatory bodies, such as the European Medicines Agency (EMA) and the FDA's CFR (Code of Federal Regulations), demand adherence to GDPs. In addition to the United States of Pharmacopeia (USP) issuing a general chapter<1029>, the World Health Organization (WHO), Health Canada, and EudraLex (the collection of rules and regulations governing medicinal products in European Union) have

published specific guidance related to GDPs. On the other hand, GDP is an important part of current Good Manufacturing Practices (cGMPs) in the US.¹¹

Definition:

Good Documentation Practice (GDP) describes standards by which documentation is created and maintained in the pharmaceutical industry. Although 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 observed GDP or face warnings of penalties levied by the FDA.

As per WHO, the purpose of Good Documentation Practices is,

· To provide the basic guide for good document practices about creation, approval, review, maintenance, correction or errors, verification, archiving, etc.

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

· To ensure that authorized persons have all the information necessary to decide whether or not release a batch of a drug for sale.

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

· To ensure the availability of the data needed for validation, review and statistical analysis. [Bhattacharya et al, 2014]

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

· To improve performance.

· Regulatory requirements.¹⁴

Objectives:

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

· Appropriate good documentation practice should be applied for the type of document

· Ensure that the document should maintain accuracy, integrity, availability, and legibility during the document life cycle.

· The document should be free from error and at any point, if the error is identified then rectify it with the proper reason for correcting including sign and date.

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

· Site Master File: A document describing the GMP-related activities of the manufacturer.

General Requirement for Good Documentation:

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

· 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”).

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

· 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 confirm 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.

· Page Numbering: GMP Documents Should Have Page Numbers Using The Following Standard „X Of Y‟ To Indicate The Total Number Of Pages In A Documen.¹⁴

· Traceable: Documentation should be traceable. Make it clear who logged the information, what it was, and when and why it was documented5.¹² [Kolekar.P et al.2021]

Format of Good Documentation Practices

Batch Manufacturing Record (BMR):

Batch manufacturing record is a written document of the batch, prepared during pharmaceutical manufacturing process. It includes real data and a detailed manufacturing procedure for every batch. A batch manufacturing record serves as evidence that batches were manufactured correctly and examined by quality control staff. For every intermediate, API, and formulation, batch production records should be created. These records should contain all relevant data regarding the production and control of each batch. Before being issued, the batch production record should be examined to ensure that it is the correct version and a clear, accurate copy of the relevant master production instruction. A reference to the current master production instruction should be included in the master document if the batch production record is generated from a different section of it. Before starting any processing, it is important to make sure that the workstation and equipment are free of materials, records, or old goods that aren't needed for the intended operation, and that everything is clean and in working order. These records should be numbered with unique batch or identification number and dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number is allocated. The batch number should be immediately recorded in a logbook or by electronic data processing system. The record should include date of allocation, product identity, and size of batch.¹³ [Tral.P et al.2022]

BMR should include:

· Dates and, when appropriate, times.

· Identity of major equipment used (e.g., reactors, driers, mills, etc.)

· Specific identification of each batch, including weights, measures, and batch numbers of raw materials, intermediates, or reprocessed materials used during manufacturing.

· Actual results recorded for critical process parameters.

· Any sampling performed.

· Signatures of the persons performing and directly supervising or checking each critical step in the operation.

· In-process and laboratory test results.

· Actual yield at appropriate phases or times.

· Description Of packaging and label.

· Representative label (commercial supply).

· Any deviation noted, its evaluation, and investigation conducted (if appropriate) or

· reference to that investigation (if stored separately).

· Results of release testing.

· All analytical records relating to the batch, or a reference that will permit their retrieval.

· A decision for the release or rejection of the batch, with the date, signature of the person responsible forg the decision. The production record review.⁷

Format of Batch Manufacturing Record

Master Formula Record (MFR):

A document or set of documents specifying the starting material with their quantities and the packaging, materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.

MFR, or Master Production Record, is another name for the Master Formula Record. Manufacturing units prepare batch manufacturing records (BMR) using MFR as a reference standard. The company's research and development staff prepares it. It includes all of the information regarding the product's manufacturing process. Any pharmaceutical product's master document is called the Master Formula Record (MFR). MFR is significant. For every product and batch size that needs to be produced, there must be Master Formula documents pertaining to all manufacturing processes. The head of production and quality control, as well as other qualified technical staff, will create and approve these. A master formula record is created using the knowledge of ineffectively qualified personnel, such as manufacturing or analytical chemists, or prepared based upon batch manufacturing record of a batch sizeg.⁸

MFR should include:

· Product Details: - Name, logo, and address of the manufacturing company

· Dosage form name. Brand name, Generic name

· Product code and Label claim of all ingredients

· Product description: Batch size, Pack size, and packing style

· Shelf life and Storage conditions

· MFR number and date: Supersede MFR number and date

· Effective batch number

· Authorization by the production and quality assurance head

· Equipment: A list of all required equipment and machines required in the Manufacturing process with their capacityg.⁸

Format of Master Formula Record

Standard Operating Procedure (SOP):

A Standard Operating Procedure (SOP) is a series of written instructions that document a routine or repetitive operation performed by personnel in a company. SOP creation and application are essential components of an effective quality system.

It offers guidance on how to carry out tasks correctly and consistently to meet predetermined requirements and produce high-quality outcomes. SOs must support ongoing enhancements to service standards and demonstrate a dedication to patient safetyg.⁷

SOP Requirement:

· SOPs shall be written in concise, step by step, easy to read follow format.

· Information should not be complicated. The active voice, and present verb tense should be used. • Should be simple and short.

· Routine procedures that are short and require few decisions can be written using simple steps format.

· Long procedures consisting of more than 10 steps, should be written along with graphical format or hierarchical steps.

· Procedures that require many decisions should be written along with flowchart.⁵

Format of SOP:

1. Company name and pagination

2. Title

3. Identification

4. Review and approval

5. Purpose

6. Scope

7. Responsibility

8. Procedure.⁵

Format of Standard Operating Procedure

CONCLUSION:

Documentation is a critical component of quality assurance and quality control systems in the pharmaceutical industry. Good Documentation Practices (GDPs) are essential to ensure the accuracy, integrity, and reliability of documentation. The "DOCUMENTS" model provides a framework for implementing GDPs in pharmaceutical manufacturing. Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Master Formula Records (MFRs) are essential documents that support GDPs. These documents provide a clear, step-by-step guide for personnel to follow, ensuring consistency and accuracy in manufacturing processes. In conclusion, effective documentation practices are vital to ensuring the quality, safety, and efficacy of pharmaceutical products. By implementing GDPs and utilizing standardized documentation tools, pharmaceutical manufacturers can minimize errors, ensure compliance with regulatory requirements, and maintain the highest standards of quality.

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Received on 13.02.2025 Revised on 20.03.2025

Accepted on 18.04.2025 Published on 05.07.2025

Available online from July 10, 2025

Asian J. Res. Pharm. Sci. 2025; 15(3):315-321.

DOI: 10.52711/2231-5659.2025.00046

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