Pains of Document Management in Pharmaceutical Manufacturing

When most industries faced a significant downfall during the pandemic, pharma was the only industry that kept growing due to unfortunate circumstances. 

The global pharmaceutical industry flourished at a CAGR of 5.4% in the past years. Resultantly, the growth rate has been estimated to reach $1494 billion by the end of 2023. 

America is the holder of the major market segment, 38% precisely. The Indian pharmaceutical industry, on the other hand, closed the financial year 2022 at USD 24.60 billion. 

Being the largest supplier of pharmaceutical drugs across the globe and the 3rd largest pharmaceutical producer by volume, the Indian Pharmaceutical industry has been growing at 9.43%CAGR over the last 9 years. 

You would be surprised to know that the Indian domestic pharmaceutical market comprises 3000 drug companies and around 10000 manufacturing units. Many of which comply with the US Food and Drug Administration regulation. 

Interestingly, these numbers are going to multiply 3 times in the next decade. 

Which means: 

1. More transactions to manage
2. Stricter regulations to comply by
3. Increased number of crucial documents to create, manage, store and dispose of as required. 
4. And high penalties in the absence of proper management.

FDA guidelines are getting stricter since 34% of Indian Pharma firms were warned of non-compliance in 2019, data integrity being the primary reason. 

Resultantly the demand for software solutions for better data management and compliance has increased significantly. 

Obviously, no company wants to pay hefty fines for non-compliance. 

But what are the other challenges that pharma companies face regarding currently used data management techniques? 

Let’s see!

The challenges pharma giants face during document control:

1. Costly storage solutions

Storing vital records in the pharma industry is way different from any other industry. Unlike regular business, a pharma company is required to store crucial documents like Batch Manufacturing Records, Equipment logs, Balance and Instrument Calibration records and many more similar documents for a stipulated period of time. 

The retention period of these documents is pre-defined and can be as long as 10-15 years and, in some cases, even more. 

This is essential since a number of audit requirements must be fulfilled before any transaction is taken ahead by the companies. These audits are done in order to judge the company’s compliance with quality, documentation, equipment and facility standards set by regulatory authorities. 

The two factors that highly influence the cost of storage facilities are: 

The ever-growing number of documents: 

Batch manufacturing records are maintained for every batch of the drug the company produces. Now, if a company makes 50 batches each day, they have a pile of 50 files at the end of each day. 

Thus, it is difficult to find a storage facility that will agree to manage such a huge slot of documents and files for a more pocket-friendly price. 

Retention period:

Having a huge stack of paper is one thing, and retaining them for as long as 10-15 years is another. 

Any storage facility would get sceptical before entering into a contract that binds them for a long time. 

And if by god’s grace you find one, good luck finding one that will help you keep those documents organized and secured from natural and consequential damages. 

2. Tons and tons of paper records

As we mentioned earlier, the retention period of these documents is pre-defined, and mostly these papers have to be stored for years. 

Since storage solutions weren’t helping, business owners also thought of renting out huge godowns and investing in real estate to solve this problem. 

Again, the ever-growing number of documents kept them from continuously updating the lot in an organized manner, and the problems regarding cost, security, and retrievability remained unresolved. 

3. Disorganization  

Another major issue which is also very common across different industries and sectors is organization. Even if companies somehow manage to invest such a hefty amount in a storage facility or real estate, they will still, one way or the other, fail to comply with the strict FDA and CDSCO compliances due to retrieval issues. 

When opting for a storage facility or even your own real-estate property to store these documents, you will have to delegate the task of organizing and managing these documents to a workforce. And the possibility of human error here is endless. 

A single mistake while tagging and labelling the documents can make it impossible for you to find the information you need in the entire lot. 

Talking about compliance requirements, let’s have a look at what all this fuss is about.

Some basic document control and retention requirements for pharmaceutical companies

While it is not possible to cover each and every FDA compliance and domestic regulation here, these are a few that companies around the globe have been fined for the most: 

1. ICH E6 (R2) Good Clinical Practices

For an effortless audit by regulatory authorities, documents related to clinical trials must be protected and retained at all costs. 

2. Current Good Manufacturing Practices

FDA 21 CFR Part 11

When it comes to managing pharmaceutical documents electronically or submitting the same via electronic mediums, you need to ensure prior that your system meets the following requirements: 

1. Audit trails
2. Security controls
3. Record generation
4. Operational controls

3. EC GMP Guide 

Chapter 4: 

Records regarding each batch of the drug shall be maintained properly so it can be recalled if and when the need arises. 

4. WHO (Finished Products) 

Every significant transaction that takes place in the process of manufacturing pharmaceutical products must be recorded at all costs so the same can be tracked at the time of quality audits by authorized persons. The same shall also be retained for a period (n+1) years. N being the shelf life of the product. 

List of essential documents along with their retention periods

1. Batch Manufacturing Records

To be retained till one year after the product’s expiry or 5 years after the batch gets approved by authorities. 

2. Analytical reports

Retained for the purpose of quality checks and control for a period of a minimum of 6 years. 

3. Master Formula and Packing Records

Every pharma company has to maintain these permanently for the purpose of PD and Quality assurance. 

Features of DMS that keep you Secure:

We think we’ve established why having a document management system is essential for your organization. Especially in the pharma industry, one cannot take the risk to avoid tools that help you eliminate any probability of mismanagement and mishandling of documents. 

For a pharma company, the following are the must-have Document Management Functionalities:

1. Audit log & activities

This is also FDA compliance for companies who use any softwares and electronic means. So companies can remain transparent in operations, and tracking the activities performed on documents becomes seamless. 

2. Security features 

A DMS with encryption and modern security safeguards is what you need to protect your data from falling into the hands of the wrong people. 

3. Document handling

If your document management system does not ease the process of management and creation of your enterprise data, then there is no point in investing in a DMS. 

The good thing is we have dox2U as an available option for you that can help you keep up with your regulatory requirements effortlessly. While also saving you from hefty penalties and headaches. 

The best thing is you can also get a lifetime free plan; you can see if you’re eligible for it on the website!