How regulations and standards affect pharmaceutical manufacturing processes

Pharmaceutical manufacturers must achieve high standards to ensure the strength of the active ingredients, quality, and purity of the final products. These standards are enforced by regulatory authorities to ensure safe and effective products for patients. The controls and checks are far more stringent than even the food industry because minute changes in the recipe can have serious consequences for patients.

Since it is virtually impossible for a medical or pharmacy professional, much less the consumer, to tell if a product is safe, or if it contains what it is supposed to contain, professions and patients expect every batch of medicines to be produced to a high level of precision and safety. Hence, the responsibility for ensuring consumer safety, lies firmly with the manufacturer, where it relies on industry-accepted Good Manufacturing Practices (GMP) to maintain drug safety and efficacy.

Regulatory authorities inspect pharmaceutical manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product. These inspections follow a standard approach and are conducted by highly trained staff. The regulatory authorities will also relies upon reports of potentially defective drug products from the public and the manufacturer. They will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the GMP regulations.


The task for the manufacturer of complying with the regulations and producing the reports is immense. Numerous complex machines and skilled employees need to be organised through the manufacturing process, which needs precise and properly recipe management. Recipe management prescribes the actions, machine parameters and documentation required to convert input materials into high-quality medicines.

In many cases this documentation is paper based, which leads to inefficiencies, potential errors, and unnecessary regulatory risks. Every time a new drug or batch is produced, a recipe with process steps and machine parameters needs to be created. Once a recipe is created, it needs be approved by multiple stakeholders. This is a time-consuming process due to the fact that not all the stakeholders will be located in the same part of the premise and often workers cleanroom garments have to be changed.

After all approvals are obtained, an operator may have to manually enters the confirmed machine parameters from the recipe into the machines. A single machine may require up to several hundred parameters! And it can have a completely unique interface, for which operators need to be specifically trained.

The whole process must be repeated for every machine, even if there are many machines of the same type with the same production parameters. It goes without saying, that this manual and repetitive work is inherently error prone. Each deviation results in more reporting, lost production time and even the destruction of an entire batch.

For each batch, the recipe data used must be archived – typically on machines or on paper. However, dispersed data storage on machines and in paper archives results in high risk of data loss, inadequate audit trail and security, violation of data integrity and GMP compliance issues. Furthermore, it makes the preparation of recipe data for reports and analyses confusing and time consuming.

Fortunately, all of these challenges can be solved with the introduction of a centralised recipe management solution, such as MePIS RM. This is a configurable software solution that digitalises all the steps in the recipe management process. It enables the creation and execution of workflows for all stakeholders, secure electronic exchange of recipe data between stakeholders and machines, and central recipe storage – all while fulfilling GMP regulations.

Furthermore, the manufacturer benefits from shorter lead times, no deviations caused by manual input errors and a huge time saving in the whole production process.

The article originally appeared on the webpage of iioTek Ltd – official MePIS RM partner for Ireland and the UK.