How Adopting an eLog Solution Helps with Regulatory Compliance

 

The pharmaceutical industry has zero tolerance when it comes to ensuring the quality of drug produced. The reason behind that is quite obvious, since even a slight deviation from the desired product can have devastating repercussions on a mass level.

The US Food and Drug Administration (FDA) has put in place certain regulatory guidelines that need to be adhered to in order to release a product into the market. In the 1990s, the regulatory body put in place a framework called ALCOA, that serves as a checklist to help with regulatory compliance. Shortly after that, FDA released a section known as 21 CFR Part 11, with the intent to help pharmaceutical companies maintain data integrity while utilizing modern technology, by ensuring all information verified through these systems check all the boxes for regulatory compliance.

Although these two frameworks were introduced in the 1990s, a quick scan of the 483s issued these days clearly points to the fact that several pharmaceutical companies struggle to meet FDA’s regulatory guidelines even today.

Most pharmaceuticals finding it difficult to adhere to FDA guidelines could benefit from solutions compliant with the aforementioned concepts and GMP. A simple way any pharma company can ensure regulatory compliance is by adopting a high-quality eLog solution.

What is an eLog?

Simply put, an eLog management solution digitizes your area and equipment logs, enabling you to verify or review them online.

It helps you capture data and details of a batch, people involved and time of an activity from an area/equipment as and when it happens, storing and preserving your logs electronically, which can be searched and retrieved at any time.

It also helps you organize your data and presents it in the form of reports that are easy to comprehend.

eLogs allow you to cut down on costs incurred in printing, storing and retaining documents and makes managing your audit easy. You can store your data securely, accessing it any time you wish to and it helps you become more sustainable by completely eliminating the use of paper.

How can an eLog solution help you with compliance? Let’s find out. For more information, Visit https://www.pharmision.barcodeindia.com/blogs/how-adopting-an-elog-solution-helps-with-regulatory-compliance/

Single Label: Replacing Traditional Methods Using Barcode Technology

 

Traditional pharmaceutical manufacturing is a complex process that involves applying multiple labels on containers to understand their status at any given point in time.

A label is applied on every material that comes in, which is subsequently replaced or additional labels applied at every stage of operations. The label affixed usually displays details of the type of material, the stage in which it is at, its approval status, the users handling it, timestamps, etc.

Once the item moves from one stage to another, a fresh label is applied to it, showing all pertinent details of the current stage.

The use of multiple labels at every stage, however, poses a bunch of problems. Here are some common problems with the multiple label approach:

Illegibility: The details are usually handwritten, so legibility is sometimes an issue. There might be occasions where what is written on a label is not clear, in which case, there is a lot of back and forth to cross-check the details.

Human error: Since the labels are manually entered and placed, there is always a chance of human error such as incorrect entries, missing entries/signatures, affixing wrong labels on a container, and even missing labels altogether at times, which can cause several drastic issues down the line.

High printing costs: At each new stage, a fresh label has to be printed for a set of containers. Now, at any given point in time, there might be hundreds of such items for which new labels are to be printed for each stage. That becomes cumbersome and involves lots of labels to be printed and increased usage of stationery and driving up printing costs.

The effort involved: In a traditional setup, the responsible person has to go to a printing station, get a fresh label printed, contents of which are to be verified by the person who prints, get a doer-and-checker sign-off, and apply them on each of the containers. And this process is repeated every time the status of the material changes (quarantine to sample test to release/rejected). Moreover, in a multiple-label setup, extra effort is needed in color coding the labels and ensuring the availability of ample stationery. It also entails locating the containers in the warehouse and bringing down containers placed at a height, applying labels and placing them back at times. This complicates the workflow, as there is a tremendous amount of effort required. For more details visit https://www.pharmision.barcodeindia.com/blogs/single-label-replacing-traditional-methods-using-barcode-technology/

All You Need to Know About ALCOA+

 

The pharmaceutical industry has a history of struggling with data management until the inception of the ALCOA+ 

framework. Its introduction has transformed the way data is recorded and managed today. In an industry where

there is little tolerance for errors and quality deviations, ALCOA+ has proved to be a boon by allowing the industry 

to integrate its data and achieve regulatory compliance.

What is ALCOA+?

ALCOA+ is a system that ensures data integrity in the pharmaceutical manufacturing industry. It is the 

brainchild of Food and Drug Administration (FDA) and its main aim is to integrate data and ensure data security.

Adopting ALCOA+ is essential for compliance to FDA guidelines and GMP practices.

Principles of ALCOA

ALCOA is an acronym that stands for
Attributable
Legible
Contemporaneous
Original
Accurate

The ‘+’ at the end of the word indicates the additional elements that are a part of the system, which are complete, 

consistent, enduring, and available.

In order to benefit from the system, it’s imperative that you have a thorough understanding of each element, which 

will enable you to implement the system successfully and reap its rewards.

So, let’s take a deep dive into the elements that form ALCOA+ and understand each one of them in depth.

Read more, Visit https://www.pharmision.barcodeindia.com/blogs/all-you-need-to-know-about-alcoa/

Why GMP is a Must for Pharmaceutical Industry

 

Every industry has its own set of challenges.

For some, ensuring a smooth supply chain is the topmost priority, while for others, the rate of manufacturing could be the most crucial aspect.

When it comes to the pharmaceutical industry, ensuring quality is at the top of that priority list. Maintaining good quality is not possible without a robust plan in place, a set of guidelines to adhere to and a foolproof audit plan.

That is where GMP comes in.

What is GMP?

GMP or Good manufacturing practice is a system that ensures that your products are being manufactured and tested in line with the required quality standards in line with industry best practices.

It is typically ensured through the effective use of a quality management system (QMS) and enables you to implement proper quality control and minimize risks.

Read More Visit https://www.pharmision.barcodeindia.com/blogs/why-gmp-is-a-must-for-pharmaceutical-industry/

Do You Know Principles of GMP for Pharma Industry

Because of the public health consequences of product quality, the pharmaceutical sector is one of the most strictly regulated industries. GMP for Pharma industry can increase productivity while maintaining high-quality standards by automating and optimizing essential operations like manufacturing and supply chain management. Quality control and regulatory standards are now included as standard features in life science ERP packages. 

GMP rules must be followed throughout the production process, from material manufacture to work environment and equipment to authorized employee training and personal hygiene. Each step of the manufacturing process must be meticulously documented in order to demonstrate that all protocols were followed to the letter. Furthermore, following Pharma GMP regulations is required for the commercialization of medications. 

Principles of GMP Guidelines 

Principle 1: Step By Step Written Procedures

To better comprehend the facility's workflows, all operating procedures and work instructions should be written down as standard operating procedures and made available to all staff. The processes should be written in a clear and logical manner so that they are simple to understand and follow. 

Principle 2: Follow Procedures

To maintain a controlled and consistent performance, it is vital that all SOPs and documented procedures are followed exactly as specified. 

Principle 3: Document Work

Documentation that is timely and correct serves as a record that aids in compliance and traceability. GMP for Pharma industry documents serves as the foundation for any investigation in the event of an error. 

Principle 4: Validate Work

Documentation of products, methods, and procedures allows for validation at each level of the manufacturing process. 

Principle 5: Incorporate productivity, quality, and safety into your facilities and equipment.

At all stages of production, the company's facility should be built and planned to reinforce the goals of quality, consistency, and error minimization. 

Principle 6: Maintain Facilities And Equipment

Monitoring the facility with appropriate documentation reduces any safety concerns and helps to avoid contamination and quality control problems. 

Principle 7: Explain, Develop, And Demonstrate Job Competency

Employee capacity building, including Pharma GMP theory and practice training as well as role-related training, is required. Appropriate training allows employees to demonstrate job expertise by creating high-quality, safe, and efficient goods. 

Principle 8: Make Cleanliness a Daily Habit

The protection of the product from contamination is ensured by incorporating cleanliness, proper hygiene, and a strict sanitization schedule. 

Principle 9: Build Quality Into The Product

Control components, manufacturing process controls, packaging, and labeling controls, and holding and distribution controls should all be in place at every stage of the product life cycle. These controls at various stages of production have an impact on the product's final quality. 

Principle 10: Conduct Compliance And Performance Audits

Conducting scheduled and periodic audits are the only way to determine how successfully GMP is being implemented. Internal audits can be done to guarantee GMP compliance, while external audits can be conducted by agencies like the FDA. 

Conclusion

Global regulatory organizations define GMP for Pharma industry as processes that ensure product quality requirements. The manufacturing process must assure that the product is safe, pure, and effective.

How It Is Important to Choose Warehouse Management System for Pharmaceutical?

Systems for managing warehouses were created to make it easier for distributors to handle, move, and sell goods in a variety of businesses. A warehouse management system for pharmaceuticals offers support for the specific needs of the pharmaceutical and medical industries in the same way it does for other industries. Pharmaceuticals are in high demand, and delivery is subject to stringent regulations. Expired drugs, audits, and storage restrictions are just a few of the difficulties the sector must deal with.

Why Use a WMS For Pharmaceuticals?

There has always been more to a pharmacy than just filling prescriptions. Patients viewed pharmacists as advisors, someone to guide them in selecting an OTC drug or understanding the dosage and directions for a prescription. Although they were always willing to help, they infrequently had sufficient knowledge of a person's medical history, allergies, or treatment plans to provide more detailed guidance. However, this is altering. Pharmacy operations are changing along with the rest of the healthcare sector.

Usage in Pharmaceutical Industry:

We are aware that Warehouse automation is crucial for every firm, no matter how small or large, domestic or foreign. We'll go over a few requirements for a pharmaceutical industry inventory management system in this article. An essential function in the pharmaceutical sector is played by the inventory management system. The logistics procedure for a business must be understood by someone who deals in pharmaceuticals. 

In this field of work, logistics are crucial for running your company as efficiently as possible. If the supply of medications is not prepared in a timely manner, it may disrupt the regular operations of an organization. Additionally, if there are any documented logistics problems, we will notice that the warehouse management system for pharmaceuticals will not operate as it should. 

Therefore, it becomes crucial to establish direct communication between the pharmaceutical supplier and the company in order for this industry to function properly. Direct contact is required since your business's operations or supply and demand conditions could alter at any time.

How does WMS Help in the Pharmaceutical Industry?

Productivity is crucial to the pharmaceutical industry.

For this, the appropriate pharmaceutical software provides you with accurate and genuine stock information. One of the key needs of today is the pharmaceutical business. Therefore, one of the most important issues for the sector is how to manage and increase production.

To increase sales, it keeps inventory expenditures to a minimum.

Sales channel is offered by well-managed pharmaceutical software. You can handle any business issues thanks to this. A strategy to cut extra costs that may be applied anyplace in the firm is to keep goods ahead of time. However, it is essential to make a correct choice, for which the node can only provide data.

It automates office procedures.

The industry greatly benefits from Warehouse automation thanks to pharmaceutical software. It increases precision and lessens reliance on manual work. The clients get a positive shopping experience thanks to effective inventory management. It increases their interest in the company. Cost computation is made far easier with automated software than it is with manual assistance.

Endings

Since the raw materials in a pharmaceutical company have an expiration date, it's critical to establish a minimum safety stock for such things. Most businesses want to maintain a minimal inventory of goods, as this makes tracking your business easier. Warehouse management system for pharmaceutical provide you with accurate and genuine stock information.

 

 

Know Some Basic Rules of GMP For Pharma

Consumers have a lot of faith in the companies that make the things they use on a daily basis, such as pharmaceuticals, car components, cosmetics, and food. When items are recalled, it can cause consumers to lose faith in them, which is why prevention is so vital. Here's everything you need to know about GMP for Pharma industry and what risks GMP covers.

Manufacturers must do all possible to cultivate and maintain the trust that has been placed in them. Implementing Good Manufacturing Practices is one way to accomplish so (GMP).

What are some of the risks GMP covers?

As previously said, Pharma GMP helps producers and customers reduce the chance of defective items being created. Consider the following scenario:

●     Contamination

      ●     Incorrect labels

Many of the laws in GMP are established to ensure that employees are thoroughly trained, equipped, and safe and that equipment is kept to an acceptable quality. In fact, Pharma GMP applies to every aspect of a company, from people to processes.

The Basic Rules of GMP

> Procedures must be carried out and documented by operators who have been properly trained.

> Procedures and instructions should be expressed in plain, straightforward language. 'SOPs,' or 'Standard Operating Procedures,' are the terms used to describe these instructions.

> During the manufacturing process, records must be kept (manually or by instrumentation) to demonstrate that all stages required by the established procedures and instructions were completed and that the amount and quality of the medicine were as expected.

> Any deviations from standard procedure discovered during the production record-keeping process must be investigated and documented.

> Records of manufacture (including distribution) must be kept and retained in an intelligible and easily available format so that the whole history of a batch can be traced.

> Care must be made to ensure that the pharmaceuticals are distributed in such a way that any risk to their quality is minimized.

> A method for recalling any batch of medicine from sale or supply must be in place. 

> Complaints regarding marketed pharmaceuticals must be explored, as well as the sources of quality flaws.

> Appropriate steps must be done in the case of defective medicine recalls to prevent future occurrences.

WHY ARE THEY IMPORTANT?

Good Manufacturing Practices (GMPs) are a crucial system that should be implemented in all manufacturing plants. They help guarantee that industrial processes and facilities are properly designed, monitored, and controlled. Companies that follow these guidelines help to ensure that their products are identifiable, strong, and of high quality. When properly implemented, GMP for Pharma Industry can assist in reducing facility losses and waste while also protecting the company, its customers, and the environment. 

The FDA establishes Current Good Manufacturing Practices, which provide a set of guidelines for producers in all industries to aspire for. They assist facilities in gaining and maintaining the trust of customers who want to know that the items they buy are made in safe, well-regulated conditions and meet government regulations.

Conclusion

GMP for Pharma Industry must be well defined and closely monitored to ensure that all products meet predetermined requirements. If any changes or alterations influence the product during this control, it should be examined and confirmed for quality. If the product's quality suffers as a result of these changes, it should be rejected.