Confidence Beyond Compliance
Pharmaceutical batch sizes manufactured to support the NDA or ANDA license application are typically scaled up to larger batch sizes after approval.
FDA Scale-up and Post Approval Changes (SUPAC) guidance provides recommendations to product license holders on scale-up of the process and making a change to the site of manufacture or testing post NDA or ANDA approval. Scale-up activities should be managed under the Pharmaceutical Quality System (ICH Q10).
Also, current regulations and FDA Technology Transfer best practice standards demand that any transfer of a technology as required to support SUPAC to the CMC documentation, is managed under the Pharmaceutical Quality System.
PharmaLex’s team of experts, which includes a number of former EU regulators, have the experience and expertise to provide support services to your scale-up operations, including:
- Working with Technical Services, Validation, Manufacturing Operations and Regulatory to
- identify changes to the manufacturing process, equipment, or site of manufacturing or testing to scale-up the batch size
- assess the changes required as Major, Moderate or Minor, in accordance with regulatory guidance
- advise on regulatory filing procedures based on the category of the changes, i.e. For US, Prior Approval supplement, Changes Being Affected supplement or Annual reportable; for EU Type 1 or Type 2 variation
- advise your SMEs on validations and/or release testing to be performed in order to confirm successful scale-up (or down) of batch size, and any Technical Transfer activities employed as part of the scale-up process.
- Providing guidance and support on preparation of scale-up documentation, including protocols which
- define the scale-up activities
- assign roles and responsibilities
- document performance of validations and/or release testing to confirm successful scale-up (or down) of batch size, and any Technology Transfer activities employed as part of the scale-up process
- apply Risk Management principles to the scale-up operation
- describe performing the scale-up under the management of the Pharmaceutical Quality System, including management of documentation, change control, deviation investigations and CAPA management
- require appropriate sign off/approval by relevant parties and by Quality on completion of the scale-up protocol
- and scale-up reports, including associated records of actions taken or conclusions reached as part of the Scale-up activities
- Providing support in the management of scale-up projects, whether within-site or inter-site, and incorporating Technology Transfer activities, to
- ensure that the key milestones of the project are identified
- ensure that the challenges to the scale-up process are identified
- ensure the application of Quality Risk Management to the process
- ensure that the scale-up process is completed effectively, efficiently and meets regulatory expectations and compliance.
Providing training on scale-up activities in compliance with GMP and regulatory guidance.
- Computer System Validation (CSV)
- Digital Health Questionnaire
- Global Procedure Management
- GxP Services
- Interim / Contract QA
- Literature Monitoring & Screening
- Regulatory Operations
- SMART MDR
- SMARTCHECK MDR
- SMARTENOVAL – analytical method validation software
- SMARTSEELVA – bioassay validation software
- SMARTSTABELITY – product stability and shelf-life estimation software
- SMARTTRANSVAL – analytical method transfer software
- Statistical Services
- Technology Enabled Services
What our clients say
I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.
Senior Regulatory Affairs Director