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OOS Investigation Tools: A Comprehensive Guide

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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi...
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Good documentation Practices (GDP) in Pharma | Data Integrity Principles

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 Good Documentation Practices (GDP) In Pharma

As we all know medicines can save life but the wrong medication can take life. Simple spelling mistakes, it will be too much dangerous to patients' life. Good documentation practice (GDP) is the most important thing in the pharmaceutical industry. It is a regulatory requirement. Every activity shall be documented in the pharmaceutical industry. Management of document, document flow from document creation/ preparation, review, approval, distribution/issuance, retrieval, obsolete, destruction, and archival have Standard Operating Procedure in every organization which is prepared by following regulatory guidelines.  

Good documentation practice (GDP) is most important because regulatory authority says, if it is not documented then it is not carried out/ not happen. Good documentation practice gives us full traceability and reconstruction of any activity done in the pharmaceutical industry. The document provides all evidence regarding particular activity like what happened? How does it is happened or be carried out? Who did that activity? When it happen? Which procedure is followed? Answers to all these questions are covered in one complete document. Everyone shall follow Good documentation practice (GDP) both on paper or in the electronic form to assure data integrity. 

Good documentation Practices in Pharma and data integrity principles

WHO World Health Organization given guidelines on ALCOA +++ Principle for Good documentation practice (GDP). This principle gives details of some basic requirements of Good documentation practice (GDP). 

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What is "Attributable" in good documentation practices?

This means that the evidence or data collected is attributable to the person collecting it. This could be paper or electronic work. 

What is "Legible" in good documentation practices?

Data should be legible, traceable ad permanent. This means that recorded data should be readable, and understandable, and should be shown step-by-step activity did that is traceable. Records should be permanent and not erasable so that they are reliable throughout the data lifecycle. 

What is "Contemporaneous" in good documentation practices?

The record should be created at the time of taking measurements or at the time of activity done. Data should be recorded at the same time it is generated or observed because this avoids alteration in data and gives the reliability of data. 

What is "Original" in good documentation practices?

Original data contains a source of data captured in the same form. This data should be reviewed and original true copies of data should be retained in complete and enduring form. 

What is "Accurate" in good documentation practices?

Accurate data means that data should be valid, correct, truthful and complete form. 

Apart from this ALCOA, the revised guideline includes some more terms like complete, consistent, enduring, and available. These terms itself show their meaning. Data should be complete. Incomplete data shows that activity is incomplete. All data and metadata are attached and arranged in one place. 

Data should be consistent means chronologically arranged with the time that is step by step. 

Enduring means data should be long-lasting throughout its life cycle. It should be retained as it is. 

And last data should be available throughout its lifecycle. Data should be accessible whenever it is needed by anyone.  

Good documentation practices (GDP) say how data should be generated and the data life cycle that should have a specific Standard Operating Procedure SOP for that. For every activity, there should be an SOP for that. For what is Standard Operating Procedure refer to my recent post 

Standard Operating Procedure(SOP)

Every person that is part of the organization should have training on Good documentation practice (GDP). Data management is a big task. so many persons are involved in data management. everyone has a specific role in data management throughout its life cycle. As per SOP data should be managed. 

Any deviation from Good documentation practice (GDP) that happens by anyone should be recorded. The integrity of data should be maintained. If data integrity bridges happen then it will be big trouble for organizations. It is not explainable to the auditors. 

There are some points to be considered other than ALCOA +++ Principle in Good Documentation Practice (GDP)

1. For correction of wrongly entered data, data shall not be corrected with white or any correction fluid. Data shall not be erased by any form, by cutting it multiple times or shall not be corrected by erasing with the help of sharp objects or with erasers.

For wrong entries, correction shall be done by simple one horizontal cut on the word and correct data shall enter. Then the reason for correction shall be written in detail with sign and date. Sometimes when time correction is required then there shall be a sign and date of the reference person who is present at that time is required. Here while doing correction in wrongly entered data, previously entered data shall be cut only with a single line as it should be readable to know what is corrected. 

2. Wherever required person should be signed along with the date. Predating and post-dating signatures are not allowed. The signature is only for the current time and date. A signature gives proof that the activity is done by or reviewed by you. A person shall not be signed for another person. 

3. As we know ALCOA +++ principle says that data should be enduring means long-lasting, to keep data long-lasting pen used for recording shall be a waterproof gel pen or ballpoint pen which is indelible. A pencil shall not be used to record the data. 

4. Data shall be recorded directly in the original form on the original paper that is in GMP records which will be kept all over the data life cycle. Data shall not be recorded on loose papers or scrap papers. Keeping loose papers or scrap papers is not allowed. 

5. As per the ALCOA +++ principle data should be complete. That also means there shall not be any blank spaces in the data. Blank unwanted spaces shall be cut and mentioned as not applicable (NA) with signature and date. 

6. Reference of data or metadata shall be given in detail wherever required. Metadata shall be attached to the main data. 

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