Case Study # 1 Full GMP audit
Situation:
A customer requested a full GMP audit of a third party contract manufacturing facility that was going to manufacture clinical material for them.
GxP Central’s Solution:
identified, communicated and coordinated on behalf of the client and conducted a full cGMP audit. The audit evaluated their system compliance to FDA 21 CFR Parts 11, 50, 54, 56, 210, 211, 312, 314 and ICH Q7A, E2A, E6. In addition, the audit included a physical review of their facility warehouse, labs, pest control, manufacturing and packaging area. After the audit a series of observations were addressed by facility and they were approved to manufacture the clinical trial material.
Case Study # 2 Blistering of Clinical Material
Situation:
A customer requested an audit during the blistering packaging process of their clinical trial material on a third party contract manufacturing facility.
GxP Central’s Solution:
Coordinated with the client’s technical, quality and manufacturing functions to be present during the complete blistering packaging process. During this time QRS performed a process vs procedure challenge related with the process, by reviewing the procedures directly with the operations step by step. This challenge produced a lot of improvement to the facility process and at the same time guarantee that QRS customer product was packaged following all cGMP and in control. All recommendations presented were accepted and improvements were done. This is a good example were the type of audits performed by QRS benefits both the customer and the audited company.
Case Study # 3 High Value API and Generic formulation
Situation:
A stakeholder with focus on generic market wanted to develop a niche prostaglandin product indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension.
GxP Central’s Solution:
Identified, communicated and coordinated on behalf of the client with several early stage developers of highly complex, high valued API. Conducted cGMP audits of shortlisted vendors, assessed their capability and capacity to deliver drug substance on time for formulation development and guided preparation of DMF with adequacy of information for drug product development. Assisted client in identifying a contract developer and manufacturer of sterile formula. Overseen technology transfer, validation batches, quality control, stability studies, quality assurance and regulatory compliance aspects during the development cycle. Facilitated preparation of ANDA for timely submission.
Case Study # 4 Production Site Transfer
Situation:
A stakeholder with more than 100+ Rx and OTC products in his basket faced severe capacity constraints to introduce new products and wanted to transfer high volume/ low margin products to CMO.
GxP Central’s Solution:
Coordinated with the client’s technical, quality and manufacturing functions to prepare technology transfer packages of eight different formulated products. Searched, identified and shortlisted suitable GMP CMOs and generated business proposals for consideration of the client. Accompanied the client core management team to short listed CMOs for the first hand evaluation and selection of CMO partner. Overseen technology transfer, validation batches, product quality and comparability protocols including stability studies. Assisted the client for preparation and submission of post approval changes to USFDA.
Case Study # 5 Re-engineering of manufacturing processes and facility
Situation:
A stakeholder of generic Rx products with in-house API process R&D unit acquired aged high volume API facility for $80 MM from a leading multinational, which failed to produce new generic APIs cost effectively.
GxP Central’s Solution:
It was engaged to identify problems associated with in-house R&D processes and overcome difficulties encountered in the scaling-up of these processes in the newly acquired facility. Introduced the concept of process engineering and statistical design of experiments in R&D to acquire and optimize kinetics data for key synthetic chemistry steps along with other Physico-chemical data such as solubility curve etc. Defined and obtained process data for product isolation, purification, and drying processes at the R&D scale to maximize throughput from available filtration and drying equipment in the plant. Conducted process mapping to identify bottlenecks in-plant facility and upgraded select equipment/utilities technologies to achieve the desired throughput.