Types of documentation in pharmaceutical industry

Completed batch records must accurately reflect what actually happened during manufacture and packaging.

Once the product leaves the warehouse, only the batch and test records remain as evidence of good manufacturing practice.

types of documentation in pharmaceutical industry

If there is an error in the record, particularly if it relates to a formulation, should be formally investigated as soon as possible. Waiting to see if the GMP auditors find it misses the point, as it may delay recovery or correction of a significant safety problem.

All procedures that may impact product quality, that is, those procedures that would be governed by GMP, must be introduced in a formal manner. Specifications need to be approved by the Quantity Department, and are not to be changed without their written approval. The requirements for starting materials must be well-defined and documented to ensure that you get the material you want, and that there are no mix-ups. Specifications for intermediate and bulk products should be available if these are received or dispatched, or if data obtained from tests on intermediate or bulk products are used for the evaluation of the finished product.

The specifications should be similar to specifications for starting materials or for finished products, as appropriate. Intermediate or bulk products that are purchased should be handled as though they were starting materials. The UIN and the standard name are used throughout manufacturing to identify that material and to trace its history from supplier to customer. A register should be established showing the receipt of starting materials. The register should include:. The standard names specified on this list should be used to label and identify starting materials during storage and manufacture.

Those of uncertain status or destined for recovery, re-processing and the like should be designated "Held" or "Quarantine".

All personnel must understand the importance of these documents. Manufacturing instructions must be followed exactly, and batch records must be accurate, be complete, and recorded in real-time. The master manufacturing formula provides a complete list of ingredients and their respective quantities to be used in processing.

These instructions must contain enough information to allow the company to re-create the manufacturing operation exactly as it is supposed to occur. They provide instructions of what to do and a record of what was done, including a list of all materials and components used and the quantities used. Batch records provide evidence of the quality of our products because operators are required to sign their name to certify that the operations took place as stated.

These labels require as a minimum the date of the operation and the signature or initials of the person applying the label. Logs and forms, such as calibration or cleaning records, document and provide evidence that particular operations have been performed. The information you are required to enter may be a signature stating that the particular function has been successfully completed, or it may be the recording of a particular piece of information that is relevant to the manufacture of a product.

Packaging documentation provides evidence that the right products have been packaged in the right container with right label, that is, the product is correctly identified. Personnel must ensure that the packaging instructions are followed exactly. The Packaging Bill of Materials and Master Packaging Instructions contain all the specific information required for labeling a product. These instructions should also include areas for calculating final yield, and for calculating the reconciliation of packaging items.

Packaging batch records provide instructions of what to do and are accurate records of what was actually done. They include a list of all materials and components used and the quantities used.

Packaging batch records provide evidence of the product quality because operators are required to sign their name to certify that the operations took place as stated. Packaging batch records provide evidence of correct product identity.

Operators are required to sign their name to certify that the operations took place in line with approved instructions, and the current revisions of the printed matter were used in the packaging operation.

It is standard practice to apply one certified sample of each item of printed matter used in the packaging as part of the packaging batch record. Testing must be performed in accordance with methods described, or referenced, in specifications. Samples of starting materials, in-process goods and finished products are taken in accordance with written sampling plans and procedures. Test records are documents that provide accurate evidence of the quality of products.Abstract Document is any written statement or proof of any activity in pharmaceuticals.

Documents are a mirror to show actual image of any pharmaceutical company. Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first.

Different documents can describe the different activity in pharma and its actual image. Various documents are producing by pharma company would be discussed below.

Documentation and Records: Harmonized GMP Requirements

Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper review of BMR, even after testing of Product from QC, product would not be released without review and completing of BMR and other documents.

Control of document is also an important part of GDP to reduce error and misuses of any documents. Master copy for all activity should be prepared such as SOPs started from Draft copy and finalizes after checking and reviewing and Approved by QA documentation.

Every document should have effective date, review date and revision no. 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.

It is difficult to make a list of required documents and totally depend upon Companies activity or environment. Followings are the activity factors considered during designing of any documents. Type of formulation 2. Country requirements 3. Classification of Documentation. They serve as a basis for quality evaluation. We need specification for: 1. Active and inactive materials 2.

Primary printed and packing materials 3. Intermediate and semi finished product 4. There are following major content of BMR.

Name of product, generic name, strength, shelf life, manufacturing date and exp date. A complete list of ingredients with full description, codes and quantity to be issued.

A statement for theoretical yield and reconciliation. A complete MFG and control instructions, sampling and testing procedure, specification and precaution to be followed. A statement for processing location and equipment. The method or reference to method to be used for preparing the critical equipment including cleaning, assembling, calibrating and sterilizing.In case we generate records only with an IT system is it mandatory to keep the raw data if we keep a scanned copy?

Is there any GDP policy regarding the register, logbook etc. Spiral binding logbook is not a good option and auditor will not allow its pages can be changed easily. In case of hand written document like ROA, if some of the details are same like reagent preparation or chemical details.

Requirements for Good Documentation Practice GDP Learn all about the good documentation practice including basics, GMP document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of GMP records.

Ankur Choudhary Print Question Forum 5 comments. Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document. The importance of documentation: As per GMP documentation control "If it is 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. Basic requirements of GDP: 1. Always record the entries at the time of activity simultaneously. Always record date with the signature in GMP records. Always use an indelible ballpoint pen to record data in GMP records. Always enter the data directly into the GMP records in the English language.

Never use a pencil or erasable or water-soluble ink pen to complete the GMP records. Never use white ink or correction fluid to correct the entry in GMP records. Never sign for someone else on any document. Only sign for the work that you have performed yourself.

Never backdate GMP records. Never discard original raw data of any kind. Never discard or destroy any GMP record unless retention period expiry is reached. Documentation and records used throughout the manufacturing process, as well as supporting processes, must meet the basic requirement of GDP.

All entries must be made at the time the tasks are performed and should be legibly signed and dated. Signatures must never be forged.

Preparation of documents 1.

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Clear and concise titles should be used for headings, tables, graphs, etc. Pages in the master document should be numbered as X of Y. Full-text spelling with the abbreviation in brackets should be used for the first time. The abbreviation may be used in place of full-text spelling in the remainder of the document. All documents should have the signature and date of the person who prepared the document, reviewed the document and approved the document.

All master documents should have an effective date, approval date, and current version number.Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Effective documentation enhances the visibility of the quality assurance system. It is a truism that it takes a disaster to happen for people, and especially regulators, to wake up and review the accepted way of doing things.

So, too, with the issue of drug safety and drug quality. The Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients developed infections.

An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose intravenous solutions that were not uniformly sterile. The Clothier inquiry, which examined the causes and contributing factors, identified several violations of what we now consider basic good manufacturing practice GMP. The chain of events that compromised the safety of the drug product included inadequate maintenance, inadequate understanding of autoclave operation, and regular deviations from the written production instructions often as an attempt to compensate for equipment malfunction.

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Together, these factors resulted in a sterilization cycle that did not assure that all vials in the autoclave were sterilized; thus, some doses were safe, while others led to sepsis in patients who received them. This incident helped to define sterility assurance in an operational way.


Processes and requirements for equipment validation were created, and legal right of inspection was explicitly given to the agency.

Validation was developed as a means of documenting systematic evaluation of the sterilization cycle — building in a safety factor — and identifying the critical parameters that need to be controlled to assure process performance.

The concept that quality must be designed into the process and cannot be achieved only by testing remains a central tenet of current good manufacturing practice cGMP. In other words, how you make something helps to define its level of quality. Preventing errors is more effective than finding rejects because it is not possible to detect all rejects.

GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination in particular, with unexpected contaminants and mix-ups for example, false labeling.

Among them, the following stand out as the most influential and most frequently referenced:. The other guidelines and regulations referred by the pharmaceutical manufacturers are as under:.

types of documentation in pharmaceutical industry

Documentation is the key to GMP compliance and 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.

Table 1 describes the 10 golden rules of GMP. Rule No. The management of each operational site is required to define responsibility for origination, distribution, maintenance, change control, and archiving of all GMP documentation and records within that department or unit. Document owners are required to ensure that all aspects of documentation and records management specified in form of standard operating procedures SOPs.

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All associates have the responsibility of ensuring that all GMP activities are performed according to the official SOPs; any deviations in procedure are reported to their supervisor and are adequately documented. The local quality assurance unit has the responsibility of ensuring via organizational measures and auditing that GMP documentation and records systems used within the operational unit are complete and comply with the relevant GMP requirements, and also that the requirements of the SOPs are followed.

Requirements for specific documents or record, including ownership, content, authorization, and change control procedures, has to be described or cross-referenced in the quality modules which relate to the subject of the document. Good documentation constitutes an essential part of the quality assurance system.Good record-keeping not only helps you during regulatory inspections GMP auditsit is mandatory to ensure your documentation practices — and your products — meet industry standards and legal requirements for safety, efficacy and product quality.

They are particularly crucial in pharmaceutical, veterinary medicine and medical device manufacturing industries, given the risk to end-users of the products e. Good documentation practices are also essential for attaining ISO certification and other industry-specific ISO certifications specific to your industry, e.

Before we discuss the basics of good documentation practices for beginnersgood documentation practices GDocP should not be confused with good distribution practices GDP. Good documentation practices GDocP aim to ensure globally-accepted standards are met in record-keeping and reporting. GDocP goes beyond being an organisation-wide requirement.

types of documentation in pharmaceutical industry

Good documentation practices requirements apply for any delivery region or country; although some countries have different GDocP requirements — DO check before you ship. What types of documents or record-keeping is required in the pharmaceutical industry or in the production of medicinal cannabis, medical devices, blood and tissue products and veterinary medicine production?

Documents and records can fall into various classification systems, and in general, there are 4 key classifications for documentation. Other Training Bundles. You can also browse our top online GMP training courses for industry-specific training, available in bundles. Onsite custom courses by Maria Mylonas are also available at your facility anywhere in the world. Connie May, B. Sci, MHST is a health researcher and writer.

Her background includes post-graduate studies in cannabis, addictions, substance use trends and health-related outcomes. Double meanings for the acronym GDP will increase your quality management system issues; so be sure you specific GDocP for good documentation practices. Aim and purpose of good documentation practices GDocP in pharmaceutical and medical device manufacturing Good documentation practices GDocP aim to ensure globally-accepted standards are met in record-keeping and reporting.

Many manufacturing businesses perform self-inspections more frequently than their annual requirement, in order to improve compliance, reduce risks and initiate continuous improvements and CAPAs as part of their quality management system QMS Internal investigations in relation to GDocP helps reduce risks related to product safety, such as interception or tampering, and are crucial pieces of evidence and batch traceability, especially during a potential product recall GDocP compliance investigations can help reduce your risks of failing a TGA or FDA GMP audit.

Just remember to include everyone in your distribution supply chain, including contractors, service providers, drivers and warehouse personnel. Documentation Types Good Documentation Practices What types of documents or record-keeping is required in the pharmaceutical industry or in the production of medicinal cannabis, medical devices, blood and tissue products and veterinary medicine production?

Primary Records examples: production formulas, supply source documents, contracts, packaging instructions Procedures or supporting procedures instructions and guidebooks, SOPs Subsidiary records help meet GMP, e. You must also attend training and refresher training for good documentation practices. Page last updated: August 1, Good documentation practice commonly abbreviated GDPrecommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

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While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.

Consistent training. Consistent control over the operation. Regulatory authority. Control of deviation. From the regulatory guidance above, additional expectations or allowances can be inferred by extension.

Among these are:. The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law e. Here are some examples where such enforcement has occurred that included departures from GDP:.

Good Documentation Practices (GDocP) | GMP Basics

From Wikipedia, the free encyclopedia. Redirected from Good Documentation Practice. Control of deviation Contents.

types of documentation in pharmaceutical industry

Ministerial Ordinance No. Response to the FDA's May 12, Observation 7. Form FDA issued to L. Perrigo Co. Observation 9A.

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Categories : Pharmaceutical industry Good practice. Hidden categories: CS1: long volume value Webarchive template wayback links Use dmy dates from April Namespaces Article Talk.Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements.

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.

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. 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 Formulae, Processing, Packaging and Testing Instructions: Provide detail all the starting materials, equipment and computerised systems if any to be used and specify all processing, packaging, sampling and testing instructions.

Inprocess controls and process analytical technologies to be employed should be specified where relevant, together with acceptance criteria. Protocols: Give instructions for performing and recording certain discreet operations. Technical Agreements: Are agreed between contract givers and acceptors for outsourced activities.

Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e. Records include the raw data which is used to generate other records for electronic records regulated users should define which data are to be used as raw data.

At least, all data on which quality decisions are based should be defined as raw data. Certificates of Analysis: Provide a summary of testing results on samples of products or materials together with the evaluation for compliance to a stated specification.

Reports: Document the conduct of particular exercises, projects or investigations, together with results, conclusions and recommendations. Your email address will not be published. Notify me of follow-up comments by email. Notify me of new posts by email.

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