This website is written by experts in Pharmaceutical Industry Manufacturing Research and Development and Regulatory Affairs Since 2008 and in 2011 Awarded as one of top 10 websites across world in Pharmaceutical Manufacturing Regulatory

Thursday, February 23, 2023

How to maintain Data Integrity in pharmaceutical manufacturing company

What is data integrity and how to maintain data integrity in a Pharmaceutical manufacturing company? 

Data integrity has very severely impacted the pharmaceutical manufacturing industry across the globe. 
'Accuracy and authenticity throughout the life cycle of the document is the requirement of the data that is generated during manufacturing of pharmaceuticals in a pharma company. Data integrity principles Attributable, Legible, Contemporaneous, Original, and Accurate Complete Consistent Enduring. (ALCOA and C C E) are described just to achieve the above objective'. 
Here they are explained in detail. 

What is the meaning of attributable? 

The document generated in pharmaceutical manufacturing and the data generated for the document should have an owner or creators who has done this work? who has generated the data, the data generated should be attributed to a person who has generated the same. For example, if one chemist weighs a product for testing his name should be mentioned on weighing slips, or his id should come on the log print. A person doing sample preparation and analysis their name should be reflected in the data with signatures at respective points. If one person does testing and another writes, report its clear case of violation of data integrity.

Legible: means the document should be readable, even if it is an old document, throughout the life cycle of the document the data should be readable. If an old paper with torned condition and partly visible faded ink is a case of violation of data integrity. 

Correct, original and accurate these words themselves give what they demand from data. Further some more principles are added in as Complete, Consistent, enduring. Consistent means the data produced should be accurate in a consistent manner, one report is correct and accurate etc. and another violation means there is no consistency. This is a very important aspect of data integrity. 

Enduring means the data generated should be such that it remains firm and valid till the life cycle of the product and data. 
One of most important point here we must discuss is maintaing integrity of data generated through computer and computerised systems. The computerised systems must be password protected and the individuals must not share their password to others.

How to maintain data integrity
Only way to prevent violations of data integrity is to educate personnel about the maintaining integrity of data even to those who are actually not directly generating data but might be part of the system. Educate about the actions taken by regulatory agencies on pharmaceutical companies across the world. Because of which many jobs were lost, no one likes to violate data integrity, but there should be a proper and continuous education, drills, and inspections to maintain data integrity. Monitoring individuals' work, training them and giving them proper time, is the key to success in maintaining data integrity. 
Another part is disciplinary actions taken by companies, there should not be any tolerance for deliberate violations. Inform personnel about such actions can be taken in advance. These are not advisable because it takes a lot of time and effort to train people to do proper work. Some companies don’t get manpower due to such actions. 

Policy of company on maintaining data integrity: The companies with honest intent and transparent business modules try to adhere to data integrity principles but the companies with ill intended habituated to do violations will never comply for data integrity unless they change policy makers itself. Management must be honest to form a policy and implement the same for data integrity.
How to handle instance of a data integrity violation?
Data integrity violation incidence should be recorded as a unplanned deviation. Proper investigation and impact analysis is required to do for the impact of the data integrity violation on the quality of product manufactured in past and in future as well.
Root cause analysis should be done for identification of the reason for the incidence.
Proper corrective and preventive action is required to be taken.
After implantation of CAPA the deviation can be closed by taking action on the persons responsible by providing them  proper training and guidance. 

No comments:

Most Popular

HEMACORD Cord blood Cell Stem Cell product approved by US FDA

Microbial load limits for water for pharmaceutical use

Ultraviolet light as antimicrobial disinfectant in water for pharmaceutical use

Why water for pharmaceutical use is always kept in close loop in continuous circulation?

Ion exchange resin and its application in pharmaceutical dosage forms, and drug delivery systems.

Why Betalactam Antibiotics require a separate manufacturing aria in a pharmaceutical manufacturing company?

Chemistry behind the allergic reactions and mode of action of betalactum antibiotics

US FDA approved first oral drug to reduce Multiple Sclerosis MS relapses

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on lables.

US FDA honours woman who rejected thalidomide and saved millions of children's from thalidomide

A Pharmaceutical exceipent Beta Cyclodextrin being used in a life saving treatment

Nanoparticles of insulin in place of painful injections in treatment for diabetes patients, transdermal , nasal drug delivery systems

Corifact becomes the first drug to treat congenital deficiency of Factor XII.

Protein which is responsible for cancer spread discovered An antisense RNA treatment or a drug could be designed to treat cancer efficiently and safely.

Novel Drugs: Cancer Chemotherapy Using Nanoparticles May Reduce Harmful Side Effects.

What is Nanotechnology, its applications in medicine and pharmaceuticals, drug developments?

Good manufacturing practices

Pharma sales jobs Find best pharmaceutical company Job

What is Therapeutic Index ?

What is Narrow Therapeutic Range Drug?

Narrow Therapeutic Drugs List

What is High Efficiency Particulate Air( HEPA ) filter ?

What is a Laminar Air Flow Cabinet.

What is an Isolator in pharmaceutical manufacturing.?

What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11?

CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

Clean Room Classification

Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---

Quality assurance in pharma industry

Quality by design concept for pharmaceutical industry

Quality by design concept in pharmaceutical industryan explanation

Data Integrity Violation prevention in pharmaceutical Industry How to prevent Data Integrity Violation in pharmaceutical Industry

USFDA WHO GMP Guidelines pharmaguidelines Pharmaceutical Regulations Information about Pharma Quality Managment System Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test

Pharma Guidelines Most Read


Readers Visit Number

This website is Authentic Source of Pharmaceutical Guidelines

This website is Authentic Source of Pharmaceutical Guidelines

Pharma Validations Quality Management System USFDA Guidelines WHO GMP Guidelines New Drug Update Pha

This website consist of detail Information about Pharmaceutical Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test