In 1972, about five deaths were recorded in Devonport, UK, when supposedly sterilized pharmaceutical products became contaminated and caused infection in the recipient. The cause of this debacle was traced to a failure to adhere to good manufacturing practices (GMP), in particular, using a shortcut in place of the written procedure.
This cautionary tale shows why documentation should be made and followed. In this post, we’ll delve into what a good documentation and records entail.
Documentation may be divided into documents and records. Documents are used to show procedures or instructions for carrying out key operations in the plant. Records are used to show that the operations are in compliance with GMP. Together, it enables companies to trace all the development, manufacturing and testing activities. This allows them to assess the quality of operations within the company.
Having poor documentation and records can lead to confusion in the standard operations. Such mistakes can negatively affect the quality and safety of a product. With a properly written documentation and records, a company accurately track the entire manufacturing cycle. This gives them the reliability they need to ensure that they produce safe and quality products.
Several types of documentation and records are used to track the manufacturing process. Some of them include:
This document shows the step-by-step procedure of how complex operations are to be executed. It ensures that employees are always in strict adherence to the standard process, thereby, minimizing the room for unnecessary errors.
The specification shows the process involved in the production of a product. It further gives a list that meticulously describes the characteristics (size, shape, colour, etc.) that is required in the final product.
This record is used to investigate any deviation from the norm during the production process. It contains information about the batch, actual yield, notable deviations and the result of the investigation.
Equipment Cleaning and Use Record: This record shows the batch what was processed by the equipment. It also shows the cleaning records and maintenance records. The individuals responsible for the cleaning and maintenance are clearly stated.
This is used for recording information about the various tests carried out. It usually contains the name and signature of the test performer, the sample analyzed, and the key results from the analysis.
The purpose of the record is to track the process from the receipt of raw materials to the delivery of the final product to end users. This comes in handy whenever a fault in a product is to be traced to its root cause.
Other types of documentation and records include Bill of Materials (BOMs), protocols, Test methods, Training assessments, validation documentation, work instructions and so on.
Documentation and Records provide little to no use if they are written poorly. Therefore, it is imperative that they are prepared adequately. Here are some general tips to follow when preparing documents and records:
The hallmark of a good document is clarity. Documents that are well-written are properly understood when they are being read or analyzed. In addition, entries should be made with an indelible ink. Mistakes should be neatly crossed out with a line and not with a correction fluid. This is to ensure that the corrected information is still readable. Furthermore, the handwritten entries should be legible to avoid ambiguity.
It is important that all documentation and records be cross-checked. This should be done by a person that wasn’t involved in carrying out the task to increase the integrity of the review. Thereafter, the name and signature of the reviewer should be indicated for record purposes.
Sometimes, standard practices do change, either due to an upgrade in an equipment or simply a change in policy. It is important that the necessary documents are similarly kept up-to-date. The presence of outdated documents can confuse some employee who can use them accidentally.
Some companies prefer to store procedures and records electronically. If this is the case, access to the system should only be made available to the authorized personnel through passwords. This is to prevent an unauthorized person from compromising data in the system. In addition, the electronic system should allow modified data to be easily traceable.
In order to prevent accidental loss, critical records that are core to the business and necessary for compliance should be backed-up. This can be achieved through the making of duplicate copies or storing them electronically. The backup documents should be kept in a secure location.
Every record prepared should contain the name and the signature of the person that made the entry. This will ensure that all records are traceable to its creator. In addition, signing for another staff should be prohibited. In a situation where a staff member is unavailable to carry out his or her duty, the task must be delegated to another qualified staff member. The final document should contain the name and the signature of the delegate.
There’s no doubt that keeping a good documentation practice will go a long way in improving the productivity of your business. It will also help you properly keep track of your manufacturing process. If this is a priority for your organization and you want to know how we can help you with GMP compliance, sign up now.
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