GDP Module for Aspen SAOps

[Audio] Welcome everyone! I am here to introduce the topic of Good Documentation Practice and Data Integrity. Over the next fifty slides, I will be providing a comprehensive overview of our procedures, policies, and governance of Good Documentation Practice, as well as how it helps us ensure the production of consistent and compliant products. Get ready to learn about the requirements that Aspen SA Operations has set for its customers. Let's get started!.

[Audio] Focus on how to ensure data integrity and good documentation practices in the work we do. Compliance with regulations set out by governing bodies is essential to successful work. Keep all records accurately and in line with the purpose of this module to ensure data integrity and meet applicable regulations. Without good documentation, data integrity can be affected, so let's begin..

[Audio] Aspen South Africa is committed to upholding global customer safety, and data integrity is a critical part of that commitment. This presentation outlines some of the policies and procedures necessary to ensure the highest standards of data integrity. The Data Integrity Governance Policy defines our undertaking to build, execute, observe, and maintain quality systems to guarantee that data is dependable. The Record Keeping SOP details the responsibilities and obligations of all personnel associated with documentation concerning the design, production, implementation, maintenance, and circulation of our products and services. The Recording of Data SOP outlines the expected practices for capturing, documenting, filing, and reporting data from both external and internal origins. Finally, the Laboratory DI Policy outlines the prerequisites for preserving the physical, technical, and procedural safety of laboratory records. Combined, these documents guarantee data integrity across our operations and the operations of the entire Aspen Group..

[Audio] Abbreviations are a useful tool when communicating in a professional setting. BMR stands for Batch Manufacturing Record, BPR stands for Batch Packing Record, DI stands for Data Integrity, GDP stands for Good Documentation Practise, cGMP stands for Current Good Manufacturing Practise, LQR stands for Lab Quality Review, MES stands for Manufacturing Execution System, N/A stands for Not Applicable, QA stands for Quality Assurance, QC stands for Quality Control, QSM stands for Quality Systems Management, SOP stands for Standard Operating Procedures, and TLC stands for Thin Layer Chromatography. It is important to understand and use the accurate abbreviations for effective communication, documentation, and meeting regulations..

[Audio] We will be discussing the General Outcomes of this Good Documentation Practice Module. Upon completion, you will have greater knowledge of ALCOA+, methods for generating records, procedures for error correction and amendment, recording date and time, N/A entry and procedure for attachments, digit recording and rounding off, significant figures, key rules for completing BMR and BPR, QC lab record keeping, filing, archiving, control, and destruction of documents. Let us review the essential points presented in this Module and begin..

[Audio] Adhering to good documentation practice is essential to guarantee documents are precise, readable, and meet legal and regulatory standards. This module will explain the elements of good documentation practice and how it can be advantageous for your organization..

[Audio] At Aspen SA Operations, one of the key fundamentals is good documentation practice. All operations records, which include batch records, bills of materials, specifications, SOPs, Protocols and so on, will enable us to produce consistent, compliant, and high-quality products that will meet the expectations of customers. Documentation will also help us stay organized, efficient, and effective in our daily operations, and also provide support for training new employees. It is essential that we know how to effectively utilize our documentation to make sure that our company is compliant, organized and efficient..

[Audio] Document types can be divided into two main categories: internal and external documents. Internal documents are used to provide information and guidance to personnel within the organization, while external documents are used to inform customers, suppliers, and other external stakeholders. Good Documentation Practice should be followed when creating, maintaining, and storing these documents..

[Audio] We'll be discussing the types of documents used in Good Documentation Practice Module. Documents are key in any quality control system as they provide a reference to ensure the process is done correctly and precisely. We'll go through the different types of documents and how they are employed in the system. Let's begin!.

[Audio] Good documentation practices and data integrity are of the utmost importance. Ensuring records are precise, thorough, and current is a necessity for fulfilling legal obligations. Additionally, any document can be subpoenaed, creating the potential for costly litigation. All involved should be aware of these risks and take responsibility for their documentation practices and data integrity..

[Audio] Documentation is an integral part of the manufacturing process. All documentation must provide accurate and up-to-date information on who, when, where, why, and how operations should be conducted, as well as proof of proper completion. Moreover, all documents must comply with the unyielding requirements of Good Documentation Practice..

[Audio] Proper documentation is essential to verify that medical products meet certain standards. GMP requirements such as accuracy, completeness, traceability, and version control must be met by documents and records. Additionally, Good Documentation Practice involves written procedures and record keeping to ensure that activities of the facility are carried out in a planned and controlled manner..

[Audio] Today's session is about ensuring good documentation practices. As we know, good documentation is essential to ensure efficient communication and quality products. To achieve these objectives, it is important to establish consistent practices that will minimize the risks of misinterpretations, minimize errors in communication and ensue great product quality. Let's have a look at how to achieve this..

[Audio] To ensure data integrity and uphold Good Documentation Practices, we must implement the ALCOA+ principle. ALCOA+ stands for Attributable, Legible, Contemporaneous, Original and Accurate. Data should be traceable back to the individual who generated the information -- using names, signatures and dates in our documentation. Data must be legible and permanent so that it can be read and understood by anyone in the future. Each entry must be recorded in real-time as the work is being performed, not after. Source data should always be preserved and data must be complete, consistent, truthful and representative of facts, with no errors or editing without documented amendments. Following these five points can ensure that data is accurate and will remain so over time..

[Audio] It is important to understand and implement ALCOA+ as part of the Good Documentation Practice module. ALCOA+ stands for Accurate, Legible, Complete, Original and Auditable and ensures that documents are filled to completion, have no missing signatures or dates, and contain consistent information presented in the expected sequence. Furthermore, data must be maintained and accessible throughout the entire retention period and readily available for review and audit, in order to ensure that documents tell the complete story..

[Audio] We are examining the significance of Good Documentation Practice. Ensuring we log the correct data in the right way is crucial for efficient customer records and interaction. As an illustration, if you have written the wrong date, you can employ an EE code to amend it. If, however, you have written something completely divergent to what is being requested, a comment will be necessary. Now, let's put this into action. Open your work book and answer questions 1 through 8. Begin!.

[Audio] Today I'd like to talk to you about good documentation practices. Good documentation is one of the core fundamentals of any successful business, and any effort to achieve a goal involves keeping clear and up-to-date records. It's imperative that the records are accurate and contain no falsification. When making entries, make sure you use only black ink with a ballpoint pen and clear, legible handwriting. Any other colour ink, pencil, correction fluid/tape or highlighters are not permitted to be used. And as a reminder, gel pens are not allowed to be used on GMP documentation either. That's all the information I have for you on good documentation practices. Thank you for your attention..

[Audio] Without the signature and date present, it is important to understand and document fully. To ensure accuracy and consistency, all entries must be signed and dated, and any comments or remarks should be initialled and dated as well. It is also important that these comments and remarks be clear and detailed..

[Audio] It is essential to consider power of attorney protocols when dealing with important documents. A power of attorney (POA) allows one party, known as the “principal”, to authorize another party, known as the “attorney-in-fact”, to take legal action on their behalf. In business, it is necessary to ensure any documents or agreements are signed by the authorized person. The abbreviation "PP" stands for "Per Procurationem" and informs that the document is signed on behalf of the principal by an attorney-in-fact..

[Audio] Workspace organization is essential when recording information. To make sure the documentation is precise and dependable, the workspace should be neat and dry. If there is an unintentional spill that renders the document unreadable, it should be rewritten following the correct format and an explanation should be supplied. This is the best way to guarantee that the documentation is reliable and recent..

[Audio] It is imperative to adhere to good documentation practices for precision and trackability within any business. Therefore, abbreviations must be kept to a minimum and only those expressly outlined in the Standard Operating Procedure or the Facility Terminology and Definitions Booklet are permitted to be utilized. To guarantee that the most recent data is used, ensure that the relevant document is changed as necessary. SF002307 is the authorized formal document for abbreviations..

[Audio] When recording names and surnames in official documents, both components are required. Documents should always be retrieved and used from Veeva Qdocs in real time and using the current and effective versions. For viewing documents in presentation mode, click the magnifying glass to zoom the documents in the green boxes..

[Audio] When dealing with alterations to correct entry errors, the use of "EE" is necessary as the reason code and only the same individual who made the original error may make the alteration real-time. Retrospective alteration is prohibited. This Good Documentation Practice Module discusses the use of "ME/CE" and "TE" when making alterations in real-time. It should be noted that the only authorised reason codes for alterations made in real-time are "ME/CE" and "TE", and "EE" should be used to indicate that an entry error was made, and that the alteration must be made real-time by the same person..

[Audio] When it comes to making corrections, good documentation practice suggests rewriting the full number, not just some figures or letters. For example, if you have something like 2341567 with a sign, date and reason code, it should be re-written as two separate numbers, 123456 and 123457, both with the sign, date and reason code. This will guarantee the accuracy and correctness of the data..

[Audio] Clear documentation is key for creating an accurate and reliable record. Poor documentation can lead to errors not being resolved and unauthorised amendments being made. In this module we have discussed what constitutes an appropriate comment and when it is better to abstain from commenting. If an error is made it is important to draw a single line through the incorrect entry and to enter the correct information, initial and date the correction with the reason for the change stated. Taking these steps will help ensure your records stay accurate and trustworthy..

Procedure for error correction or record alteration/amendment.

[Audio] When making corrections to information, it is advisable to rewrite the full number instead of just changing some figures or letters. Also, when taking notes or commenting on documents, one must take care to make sure that no inappropriate comments are written..

[Audio] It is essential to ensure accuracy when dealing with errors and record amendments, and documenting correctly is key to this. If an error is identified, an EE code can be used to correct it. When the request is different than what was originally recorded, a comment may be necessary to give clarification. Therefore, it is essential to document these amendments in the appropriate way..

[Audio] When omitting an entry initially, make sure to include a comment stating that the entry was documented at a later date along with the reason for omission. Initial and date the comment when the late entry is documented. In order to ensure accuracy, provide an explanation for the amendment and verify the amendment with a second source. It's important to remember that late entries are not allowed unless they are verifiable..

[Audio] Case study An example of the importance of late entries in documentation can be seen in Stage A. In this stage, additional issues, signatures and a form must be received and verified in order to make sure that all the information is accurate. This information should then be referenced to a secondary source and verified on a specific date to ensure accuracy. Adhering to Good Documentation Practices during this process is essential to ensure traceability and reliability..

[Audio] Correcting or amending records is a critical component of Good Manufacturing Practices. It is necessary to make sure that only the individual who originally made the entry can perform the alteration. In rare cases, non-critical GMP data may be changed by someone else who has the relevant backing data. Any changes must be authorised by someone senior who has the appropriate qualifications. Those in the pharmaceutical team must not alter entries made by those outside the pharmaceutical team. Errors made by operators or technical manufacturers must be amended or authorised by the Production Team Leader who is in charge of the shift. Errors by Pharmacist Assistants must be amended or authorised by a pharmacist from the same shift. Any mistake made by a Pharmacist can only be corrected by another Pharmacist with the same delegation and working in the same area..

[Audio] In accordance with Good Documentation Practice Module, for any record alteration or error correction procedures, a comment can be made to refer to the page that the information has been recorded on if the space on one page is not sufficient. Each comment or correction must be accompanied with a unique number identifier that should be recorded on the same page. It is imperative that any amendments are done neatly and in an orderly fashion, with comments written in numerical sequence at the bottom of the page..

[Audio] Having accurate documentation is paramount to any successful project. It is essential to have an understanding of the lack of space that is available for comments, as well as having unique numbered identifiers and a numerical order of comments at the bottom of the page. To ensure effective use of documentation, it is important to exercise based on error correction. This will help to ensure that documentation is as clear and concise as possible, and that any issues or changes can be tracked quickly..

[Audio] Adherence to a strict standard when it comes to tracking date and time information is essential to guarantee accurate data recording and tracking. Visually mapping out this process by using a whiteboard can help ensure greater clarity about how the information should be recorded and tracked..

[Audio] Maintaining an accurate and up-to-date record of all documents is key to Good Documentation Practice. This includes not just the documents circulated, but also those rejected or stored for future use. Keeping track of every document's status allows for greater organization and safer data management. This is why we encourage you to always check that the ‘N/A of Entries’ field is up-to-date and to update it every time you add or reject a document. Doing this will ensure that all documents within the database are accounted for. It’s simple and it could save you a lot of time in the future." It is essential to maintain an accurate and up-to-date record of all documents, circulated, rejected or stored for future use. Doing so will allow for better organization and data safety. For this purpose we recommend making sure that the 'N/A of Entries' field is always up-to-date and updated when a document is added or rejected. This small step is key to ensuring the complete overview of the documents in the database and could save you time in the future..

[Audio] It is essential that all Not Applicable fields are correctly initialed and dated. This is vital to ensure accuracy and adherance to company policies. All N/A's must now be initialled and dated, even if the reason is obvious. Should an N/A be present and the reason obvious, then no comment is required. However, if the reason for N/A is not clear, a comment should be added to document it..

[Audio] We'll be discussing good documentation practices and how they relate to our cancellation policy. When canceling a full page, it is essential to make sure that all sections, sub-sections, and notes are documented properly. Every single detail should be taken into consideration to guarantee that nothing is missed and that the cancelation is in line with all our policies. Attention is appreciated and continuing the discussion is expected..

[Audio] Ensure accuracy of data and information by following good documentation practices. For example, correct incorrect dates using the EE code and add a comment to explain the purpose if something different from what was requested is written. Make sure to review your work book and complete question 9 and 10..

[Audio] The procedure for attaching addendum pages to documents must be understood. To properly affix an addendum page, the document must be printed. The addendum page should then be printed on a separate piece of paper and the two should be stapled together in the top left corner. Aligning the addendum page and document correctly is necessary for the information to be readable. Placing the sheets in the correct order within the document will make the addendum page information accessible..

[Audio] It is important to always attach associated records to the original record when documenting and creating the production process. Labels such as Equipment Control Labels (ECLs), Autoclave Labels, Dispensing Labels, Loss on Drying (LOD) results and printouts should all be directly attached to the batch record. This will help maintain the linked data and records in a safe and organized manner. It is also important to verify the documentation details of these attachments before affixing them to the document, to make sure the correct attachment to the correct document is being made. Taking these steps will ensure secure and accurate documentation of the production process..

[Audio] Good documentation practice is essential to ensure information is properly understood. When someone signs off on a step, they must verify that they were present and saw the process. Additionally, when dealing with numbers and data, any leading zeros should be omitted unless specified in a document. Thus, we would record 5 instead of 05, and 100 instead of 0100. Moreover, the process data should be written with the same number of decimals, and decimal points should be distinct and clear. With these principles in mind, we can make sure our documentation practice is as effective as possible..

[Audio] Documentation practices are important for accuracy and clarity in records. It is important to understand the "verified by" process to ensure records are accurate and the right people are accountable. To maintain accuracy, it is important to only retain the necessary number of significant figures for a given number. When rejecting inaccurate figures, always round up if the rejected figure is five or over, and round down if the rejected figure is four or under..

[Audio] Essential to understanding the key rules related to documentation best practices is Rule 3, which states that when using addition and subtraction, the answer should be rounded off to the same number of decimal places as in the least accurately known number. Rule 4 explains that when multiplying or dividing, the answer should be rounded off to the same number of significant figures as contained in the least exact factor. For further clarity, examples for each rule are provided in the slide..

[Audio] It is important to be aware of when an EE code should be used and when additional comments are needed to adhere to Good Documentation Practice. For instance, when an incorrect date has been written, an EE code can be applied to directly revise it. But if something doesn't meet the request, a comment must be added to clarify why. To get a full grasp of Good Documentation Practice, ensure that all queries are answered and exercises within the workbook are completed..

[Audio] Without greetings, without beginning with Today, and without thanks: Accountability concerning Batch Manufacturing and Batch Packaging Records being fulfilled is critical. Any signoff or initials signify that the procedure was either observed or audited later on. Definitions for those signatures are stated in the given table. It is essential to make sure these are entirely comprehended..

[Audio] Ensuring relevant records are only copied by authorised personnel is important. According to this module, authorised copies may be made by Quality Assurance Manager, Operations Manager, Engineering Manager or Quality Systems Manager. Those not listed are required to seek permission from the aforementioned personnel before making copies..

[Audio] To ensure the security of files and records and to guarantee that only authorised personnel can access them, the Good Documentation Practice Module - described in the SOPs of the Aspen SA Ops Facilities Quality Management System - must be followed. The QSM/QA Delegate and Release Pharmacist will regulate access to the Document Store documents. Unauthorised personnel may be allowed to view the documents in the Document Store, but must not take them away. When it comes to the audited or released documents, batch document reviews should take place in the Release Office, and the Release Pharmacist needs to be present. Unless there are exceptional circumstances, taking documents away from the site is not recommended; if such a request does arise, it should be authorised by the Quality Assurance Manager or Quality Systems Manager and noted in the Document Register..

[Audio] It is essential that all documents, records and/or files are authorised by the LQR and/or relevant Managers before any additional information or comments are made. Additionally, all obsolete documents, records and/or files should be archived in the Document Store for long-term storage, or where required, stored off-site by an approved subcontractor. When a new effective document is printed, the superseded/retired document should be destroyed so that it is unusable. The user that printed the new document is responsible for making sure that the superseded/retired document is destroyed, as part of our Good Documentation Practice Module, to ensure accurate records are kept..

[Audio] Document destruction is an essential aspect of proper documentation practice. If a user wrongly enters data on a standard printed form, a line should be drawn through the page or pages of the document, with the user writing the reason and signing and dating it. The outdated or obsolete document must then be destroyed in a way that makes it unusable, such as scratching and shredding. The user who printed the new current document is responsible for making sure the obsolete or retired document is destroyed. Thank you for listening..