The key to effective technical transfer is to clearly map out the transfer process and to carefully select and carry out good due diligence of CMO partners with experience in developing the drug dosage form you are looking to transfer. This means engaging with CMOs who can leverage pilot scale equipment as part of the qualification to find the optimum processes early in the development life cycle, iron out kinks and plan qualification activities. It is key to identify these process technologies early and once down selected to then minimise the level of change and added complexity as the development and scale up progresses. The client and CMO can learn the sensitivity and behavior of the process early and manage or avoid potential pitfalls.
Another critical consideration is robust formulation development. Scale up and process optimisation can improve the performance of a manufacturing process but only if there is a solid foundation and a robust formulation design in the first place. The client and CMO must also complete process qualification to verify that the transferred process is reproducible during industrial scale commercial manufacture. The key is to ensure that quality has been designed into the process and critical control process parameters and material attributes are identified that control the quality of the product during manufacture rather than just relying on final test results.
Selecting the type of Audit
Remote audits may not suit every situation, and the first step is to assess whether an onsite audit is required or if a virtual audit would be appropriate. The initial assessment of a new critical supplier or facility to determine if the quality management system is adequate and the site capable of manufacturing or storing the product to be supplied may require an in-depth multi-day onsite audit. The company and its QPs/RPs need to get a feel for the general levels of housekeeping, cleanliness, and maintenance. They must determine if the facility is well designed and laid out and has the capacity to manufacture or hold the volumes required to GMDP standards. Follow up routine audits of suppliers initially deemed GMP/GDP compliant (with minimal observations from the initial assessment) would be lower risk. In this situation, it would be appropriate to conduct a remote audit. The most essential tool in determining what type of audit to complete is the periodic audit risk assessment. The company should assess the risks associated with individual new suppliers through the change control program and determine if an onsite audit or virtual audit should be added to the audit program. Also, periodically the entire program should be assessed to determine if the types of audits are appropriate and if in-person visits or virtual assessments can be completed.
For virtual audits, it is critical to plan for success and ensure the site to be audited will have appropriate recording equipment and adequate broadband/Wi-Fi availability to allow the entire site to be visited virtually. It is also essential to verify with the site to ensure that SOP’s, records, data and other documentation can be shared with the auditor using a secure data sharing program such as OneDrive or SharePoint. Often suppliers who supply large numbers of customers and who, as a result, have frequent audits will have detailed documentation packs and walkthrough videos prepared that can enhance this process. This will allow the initial site tour and document reviews to be completed offline and free up the auditees. The interviews of key personnel and question and answer sessions can then follow this.
The organisation needs to determine who will conduct the audit or audits, assess their capabilities and approve the individual plans or audit programs. Also, an evaluation of whether to use their in-house team, QP/RPs or engage outsourced specialist consultants will be required.
Orion Consulting has a panel of highly experienced auditors with many decades of GxP, laboratory, and facility assessment experience. We can work closely to identify the right expert for your audit requirements, whether supplier assessments, storage sites, testing laboratories or internal or external manufacturing sites.
If you need an immediate assessment of your audit program or have a critical or urgent audit that you need to address then, please contact us at firstname.lastname@example.org
The QMS consists of all of the manuals, policies and procedures required to ensure that regulated processes are carried out in a controlled manner and ensure that the company manufactures high quality, safe and effective products.
The main benefit of designing an effective and comprehensive QMS is that it provides consistency. So that every time a process is completed, it is carried out in the same way and to the same high standards. This will mean that employees can access the Standard Operating Procedures (SOPs) and get detailed instructions on how to carry out each task without any deviation from the expected highest standards of research, investigation, reporting and documentation.
A well designed QMS will also include feedback mechanisms to assure continuous improvement. Where deviations occur CAPAs should be implemented to ensure that the identified root causes of issues encountered are eliminated or mitigated as much as possible. Similarly, effective management review will ensure that the system and processes are regularly reviewed and any identified trends are actioned appropriately.
Improve efficiency, cost and customer satisfaction
Finally, a well-designed quality management system will also complement other business processes and will lead to streamlined and efficient practices. When developing procedures that meet the regulatory and licensing requirements companies often utilise business excellent best practices to drive efficiency, cost improvement and customer satisfaction.
Orion Consulting has decades of experience in implementing compliant quality management systems that are correctly suited for the GxP type or phase of your products development lifecycle. So whether it is an initial GCP QMS to allow your products to enter clinical development, or a QMS for a Marketing Authorisation Holder (MAH) and commercial distribution via a WDA, we can assist.
To discuss your needs further contact us at email@example.com.