The greatest news for any pharma manufacturer organization is approval from regulatory bodies to continue or start manufacturing and market their products for a specific region. This news comes after a great deal of work and effort put together by all sections of a pharma organization to fulfil all regulatory requirements.

This requires a high cost of investment, training, upscaling and changing the current system in an organization according to the requirements of a specific regulatory body or, most commonly, the United States FDA. 

A regulatory body is only responsible for outlining detailed guidelines about the body's thinking regarding the drug requirements, expectations from the pharma manufacturer, and procedures to adopt for acquiring accreditation from the regulatory body. However, it is the sole responsibility of the manufacturer to devise methods, procedures and techniques to fulfil these regulations.

Upon notice from the pharma manufacturer about the readiness of the entire facility, the regulatory body will inspect and review each section and minute details of the manufacturer’s readiness. It will inspect to see whether the pharma manufacturer has put together all the requirements necessary for the execution of the pharma manufacturing process.

The regulatory body will only review adherence to their regulations and will not facilitate adherence. After inspection, it will give its final report, indicating whether the manufacturer is allowed to execute manufacturing processes or not. It is the sole responsibility of the manufacturer to fulfill all requirements

List of some common Audit Bodies

When applying to sell/market their products, pharma manufacturers are responsible for adhering to local regulatory body requirements. In addition, adherence to critical or renowned regulatory bodies helps pharma manufacturers increase their portfolio. Some famous and critical audit bodies include the United States FDA and EU GMP.

Let's briefly discuss each of them. 

United States FDA GMP

The United States FDA is the drug (along with food) regulatory authority for the United States market. It laid down different guidelines and regulations for pharmaceutical suppliers and manufacturers to follow and implement in their product life cycle. 

The specific guidelines for pharma products are known as Good Manufacturing Practice - GMP, which covers all pharma product manufacturing processes, sections and components.

EU GMP

EU GMP is the European version of GMP that provides a detailed guideline for manufacturers of pharma drug products. 

Every manufacturer that intends to sell / market in Europe is bound to follow these regulations.

Tips for making your facility audit ready

Let's discuss some tips for making your facility GMP audit-ready. We will not discuss actual regulations but share some tips on optimally implementing them.

Understanding the importance of GMP

Your first step towards implementing audit policies should be understanding GMP and its basic & core ideas. It helps motivate employees and management because acquiring GMP guidelines for the US FDA can become tiresome. In this regard, the following can help us understand the importance of GMP.

· Your facility members must know what GMP is and what it means for implementing GMP in your manufacturing facility. You should know its importance in pharma manufacturing and what benefits it will offer to the organization and personnel. It is also necessary to know about the changes in the existing system, methods and procedures.

· Another area to understand GMP's importance is what area it would cover. Do the current practices implemented in the existing departments, areas, components and systems comply with the GMP regulations, or must they be changed according to the GMP requirements? Knowing what areas it covers and whether implementing GMP in all components of GMP is beneficial for our organization or not?

· Another point of attention in understanding the GMP is why it is necessary to implement GMP in your organization. If products produced by your organization are suitable enough to be marketed in your region/country, implementing GMP will open doors to new markets/regions/countries. It will also develop trust among regulatory bodies and end-users in establishing the quality of your products, processes and components. 

· It is also necessary to understand capabilities and expertise of current employees. Do knowledge, skill and experience is enough or whether it needs an upgrade

GMP Gap Analysis

After your facility has decided to implement GMP, the next stage is to determine gaps in the existing system in implementing GMP. Its main purpose is determining what existing systems, protocols, areas, equipment, and quality protocols must be updated per the GMP guidelines. 

The main aim of conducting gap analysis is to determine weak points in your system and the extent of change required to make it capable of a GMP-ready facility.

It can be performed by

· Individually identifying the concerned area for which the GMP regulations will be implemented and what are the desired objective of that particular area ( which in turn will depend on the GMP guidelines)

· Establish the expected outcome of the gap analysis activity of a particular area/ process. 

· Start the gap analysis by determining what areas/processes fall short of the GMP regulations and identify the reasons for not fulfilling the desired target. It can also be beneficial to compare the current state with the expected state.

· After analyzing the gap, describe the extent to which the gap lies in the existing system, area, or process. It usually involves describing things on a numerical scale for easy understanding and recommending remedial actions. 

· After completing the gap analysis, compile and record the recommendation in a report of appropriate format. This report will become the basis of future decision-making regarding GMP readiness.

· The gap analysis should be prepared for all departments requiring GMP compliance. Typically, it includes

· Quality practices

· SOP

· All QMS processes, such as Risk Assessment, Documentation, and CAPA

· Maintenance procedures

· Validation activities

· Laboratory Practices

Documentation 

Documentation is integral to the pharmaceutical industry, and all processes must be documented. FDA inspectors specifically focus on documentation; if documentation is not available for a process, it is not performed and is not acceptable by the FDA inspectors.

When preparing your facility for GMP, documentation plays an important part and can make or break the entire accreditation process. 

List all the relevant documentation for a process or an area and thoroughly prepare them by adding al the required details and information. Some documentation includes, but is not limited to,

Quality Manual - A document to describe the organization's commitment to implementing quality in all the processes and final product. Often, it also serves as the foundation of a Quality Management System. 

Standard Operating Procedures (SOP) - SOP defines the procedure of doing or executing something most appropriately. SOP must be prepared for all the critical processes, such as product manufacturing, calibration and performing lab tests on a product sample.

Records - Various records indicate the authenticity and validity of a particular process. Once the attached process is executed, it’s record must be updated with proper authorizations and approval. Some records include, but are not limited to, the following.

· Manufacturing records – manufacturing records indicate the process every product has gone through.

· Maintenance records. It includes all maintenance on the facility's equipment, machines, and instruments. It also consists of the records related to preventive maintenance, which is performed to prevent breakdown by a faulty part or component.

· Testing Records. It includes sample test records in the quality laboratory. These records include details of the sample, the department collected, and the results.

· Calibration records - calibration is a critical requirement for the pharmaceutical industry, where each instrument is checked for accuracy. Its records must also be maintained for review by regulatory body inspectors.

· Manufacturing records. These records consist of the process followed while manufacturing a particular product. It includes all the details and indicates whether a manufacturing process has been done according to the approved SOP.

All relevant records, especially the SOPs, must be valid and not expired because these records have expiry dates. When expired, they must be promptly update to show the effectiveness of the relevant documentation.

Training 

Training is a detailed process by which personnel or participants get to know and perform any system in an ideal and safe way to achieve the desired results. An expert can transfer available knowledge, skills, and expertise. 

For the pharmaceutical industry, it is one of many ways to ensure the quality of the personnel working directly on the plant floor. Although the workfore is hired for every process and the department is qualified, training helps to update, recall, and remember them about the pharma process, equipment, and product.

Training is a vital requirement to become GMP-ready. The organization is responsible for devising an effective training plan for all relevant employees, aligning with the latest organization's processes, product quality & safety.  

Training schedule is a critical related documentation that must maintained, involving all relevant records.

Training Schedule is a schedule developed for all the personnel of all relevant departments. It should include the date, time and venue details for training. The training schedule should be devised with the availability of all personnel in view. It should include realistic topics that personnel face while in the pharma industry. 

Attendance records should also be kept to identify any missing personnel.

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.