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How technology can help solve top 3 FDA compliance challenges

Vivek Gera

Non-compliance is the biggest threat to the growth story of the Indian Pharmaceutical Industry today. The number of warning letters issued by the FDA has increased drastically since 2016 (chart below).

The cost of a single non-compliance event is tens of million dollars and this does not even include the loss of market capitalisation and reputation. Since the year 2000, Drug manufacturers have lost over USD 3 billion for drug safety violations.

The reasons for non-compliance are quite diverse and spread across People, Process & Technology. Compliance is an evolving domain and, more often than not, Pharma companies have been slow to adapt to any major changes in regulations. This is evident from some of the emerging trends of reasons behind non-compliance.


Manufacturing Compliance of Finished Pharmaceuticals is governed by the Code of Federal Regulations 21 CFR Part 211. While the reasons for non-compliance are widespread across various aspects such as Process Design, Qualification, Monitoring, Behavior, Systems, etc., here are the Top 3 reasons that have emerged recently.


Since FDA started issuing warning letters for data integrity fifteen years ago warning letters for identified failures in computer system validation, failure to review laboratory computer systems audit trails, failure to maintain electronic records and failure to investigate their disappearance — the volume of warning letters containing a violation of data integrity have grown to ~80% of all letters issued.

Realizing the gravity of the situation, on April 14th, 2016, FDA published a new document “Data Integrity and Compliance with CGMP”.

The data integrity-related CGMP violations have led to severe consequences for the firms, including warning letters, import alerts, and consent decrees. Some key observations are:

  • Lack of control over access to computerized systems
  • Non-contemporaneous record-keeping
  • Deletion, falsification, alteration, or other manipulation


Cross-contamination has been the most debated compliance topic of the year 2018.

The industry is slowly adopting HBELs (Health-Based Exposure Limits) ever since EMA (European Medicines Agency) published its Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.

Regulators are now looking not only for science-based cleaning acceptance limits but also Statistics based alert limits keeping cleaning process capability in mind.


Releasing a drug product without a proper assessment of the quality of the drug product leads to this type of issue in the warning letter. Nearly one-fifth of all compliance issues are due to the incorrect or immature release of the product.


Conventionally, the Pharma industry has been slow in adopting newer technologies than some of the other manufacturing industries such as Oil & Gas, Mining, Automobiles. This is often attributed to the regulated nature of the industry as well as a lack of strong IT leadership.

Most production and compliance systems are still paper-based and suboptimal. As per a survey, 90% of the drug production facilities don’t use any computerized systems for compliance management.

A 4 Step Guide To Building Compliance 4.0

Compliance 4.0 is all about digitalization and automation of the Compliance Management Processes to achieve better compliance metrics in terms of product quality, patient safety.


Digitization is the key requirement in starting to build a strong compliance future. Some of the common issues such as missing or inconsistent data patters can be eliminated by simply digitizing the records.

However, Digitisation in Pharma has been at least doubling the price than some of the other industries due to a limited number of suppliers with domain expertise across technology and pharma.

Due to the lack of new and innovative solutions. This is where the industry needs work with a lot of startups to arrive at low cost yet innovative and robust hardware and software to bring the systems online.


Most legacy systems used in the Pharma Industry today work in their isolated silos. When multiple production, compliance and business systems come together, there is an added opportunity to integrate them and manage change proactively leading to better compliance.

Integration also presents other benefits such as boosting productivity by eliminating wasted efforts in managing multiple systems in isolation.


Pharma industry has been very strong in developing standardized processes, not just compliance but across the whole supply chain. This can be readily leveraged to build automated workflows which are ten times faster and error-free leading to the elimination of data integrity related compliance challenges.


The adoption of a strong data-science program across various functions can improve the bottom line by as much as 10%.

A compliance 4.0 plan will not only manage the compliance workflows but also prevent non-compliance from happening in the first place.

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