Documentation in the pharmaceutical industry is key as it gives clear evidence of what has been done throughout the product life cycle. This includes sourcing raw materials, manufacturing processes, lab testing, packaging, storing and distributing. Documenting accurately will ensure processes are done consistently. As quality, safety and compliance are key factors in the industry having good documentation will help with accountability.
Having good documentation will help to create standard processes within the pharmaceutical company. Standard Operating Procedures are documents showing how certain processes should be completed, who should complete them and what controls are needed. This will ensure employees carry out tasks consistently within different departments and shifts.
Batch records are one of the most important documents within pharmaceutical manufacturing. They show what was used within the manufacturing process including materials, processes, equipment, parameters, roles and any observations. Having full and accurate batch records will allow the manufacturer to show that processes have been completed using approved methods and will help to review key information from manufacturing.
Having good lab documentation will help with quality. This includes sampling, method, results, calculations, equipment, and review documentation. By having accurate records we can show the lab testing is reliable. If there are any unexpected results having accurate documentation will help investigate the issue. The Quality team will know if further investigation is needed.
Equipment and maintenance documentation will help show that the equipment is well maintained. This includes qualification records, calibration certificates, cleaning records, maintenance records and equipment usage. This will show that the equipment is being maintained correctly and is suitable for the intended use. This will help identify any reoccurring issues with equipment and help plan preventative maintenance.
Documenting plays a large role in deviations and corrective action. If there has been an issue with a process during manufacturing/quality it needs to be documented and investigated. This will help to identify the possible cause of the issue, assess the impact on the product quality and find suitable corrective and preventive actions. Keeping good records will help organisations keep track of any actions taken.
Training records are another important aspect of documentation. The manufacturer will need to ensure employees are trained to do the right things. Having training records will show that staff have been trained to do the right things. This includes training on processes, hygiene, equipment, safety and quality. Regular reviews will help keep staff up to date with training needs.
Technology has had a large impact on documentation within the pharmaceutical industry. Using electronic documentation systems, electronic batch records, quality management systems and lab information management systems can help with keeping records accessible, amendable, traceable and efficient. However, electronic systems need to be properly validated. They need to have proper controls in place to ensure they are secure, there are audit trails in place, back up and data integrity.
Data integrity is very important within pharmaceutical documentation. Documents should be attributable, legible, contemporary, original or copy, and accurate. Data should be recorded at the correct time and cannot be altered without authorisation. Having strong data integrity will help ensure decisions are made using reliable evidence.
When choosing a manufacturer for your pharmaceutical company it is important to consider how they handle documentation. Consider how they control their documentation, batch records, lab documentation, change control, deviation investigations and data integrity. Having clear documentation will help to communicate effectively with your manufacturing partner.
Bioaltus Pharmaceuticals Pvt. Ltd focus on quality driven pharmaceutical manufacturing. We have good processes in place, experienced staff, modern facilities and quality processes. Good documentation and control of processes will help to ensure manufacturing is done consistently.
Overall, documentation within the pharmaceutical industry is extremely important. It will help you to have evidence of how products are manufactured, tested, handled and controlled. With accurate documentation, processes are done using approved methods, data integrity is improved and the right systems in place this will help to improve traceability, compliance and give confidence that products are of high quality.
