Know the Regulations and Standards

Data Integrity App

 

01) 21CFR Part 11

21CFR 820

03) FDA Guidance

04) MHRA

05) GAMP

06) ISO

07) WHO

08) Others

Pharmaceutical regulations across the world play an important role in ensuring the safety and efficacy of the approved drugs. They not only regulate the pricing of drugs but the quality as well.

The regulations are required both for new innovations and already existing products, in order to improve health status. Both products which are produced domestically and those imported from other countries require regulation.

Companies need to be aware of the FDA regulations that they are required to meet, in order to ensure quality compliance and safety for the products they manufacture


What Are They?

A cGMP is a set of regulations that form the base for systems that allow the FDA to ensure proper design, monitoring and control of processes and facilities involved in pharma manufacturing.

Once they are adequately put into practice, cGMPs can reduce the occurrence of errors, deviations, failures, contamination, mix-ups and other issues

Compliance with them allows companies to enhance product quality and assured standards. This is done through a process of establishing and strengthening the systems used for procurement of raw materials that meet quality standards, proper operating procedures, quality management, detection and investigation of any deviations as well as strong methods for testing and FDA process validations.


Why Are They Important?

Drugs and other pharma products cannot be defined as ‘good’ or ‘bad’ by smelling, touching, tasting or looking at them, so it’s essential for consumers to have some assurance about their safety and efficacy.

Testing processes are included in cGMP guidelines, but they are typically conducted on small samples from each batch, which makes the establishment of proper manufacturing processes and conditions essential.

The inclusion of cGMP regulations helps manufacturers ensure that quality is built into every stage of the product design and manufacturing process.

 

What Happens If Companies Don’t Meet FDA Regulations?

Companies that do not comply with these objectives may find themselves facing regulatory actions, the severity of which will depend on the nature of the violation.

For instance, if a product does not actually offer the benefits it claims, the FDA can ask for a recall. Most companies will willingly meet this request, but those that do not may find their products seized for a forced recall.


“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


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