GMP & Quality Assurance Consultancy Services
Through our knowledge and experience in the pharmaceutical and medical device industries we can assist you in the development and improvement of your facility's quality systems to EU cGMPs and applicable EU Directives as well as respective ISO standards, as applicable. Our advice always takes into consideration that although regulatory compliance is of the utmost importance, the financial performance of a site is critical. We therefore aim towards a quality system that meets regulatory compliance and at the same time is practical and manageable by the facility's resources.
The following is a non-exhaustive list of areas in which we can provide consultancy services:
Quality Management System Consultancy
If there are areas within your quality system that need improvement or if you are just setting up, we can provide advice as to how it would be best to set-up a quality system for your particular site.
If yours is a new site, we will first meet with your personnel to understand the operation and then write the standard operating procedures and other required documents that provide the back bone of the QMS. Afterwards, we will train your personnel on the issued documents and coach them in the management and implementation of the new system.
If on the other hand, you have already a system in place but you believe that there are areas that need improvement, our strategy would be to first conduct a gap-analysis of your current system. Following that, we would issue a report that would identify areas that are non-compliant. We can further assist with implementing improvements in these particular areas.
GMP Audit Report Response
Following a regulatory or customer GMP audit, there may be particular situations (situations that no one enjoys being in!) where the observations raised are rather critical in nature. The response for these types of observations has to be a detailed remediation plan with the appropriate root cause analysis, provision of documented evidence and a well-defined corrective and preventive plan. That being said, it is important to balance out the amount of information being provided as, in some instances, too much information raises more questions than those being answered. A professionally written response report can make the difference between losing a customer, or worse, losing GMP certification of the site as opposed to showing to the auditor that the site has taken the matter very seriously, has set all the necessary resources to deal with the observation identified and that a corrective and preventive action has been defined, taking also into consideration other areas where similar non-conformance could occur.
So, where do we come in into all of this?
From the moment you receive the audit report we will guide and assist in:
- conducting a root cause analysis of the observation/s
- planning for the appropriate corrective and preventive actions
- generate the documented evidence necessary to substantiate the conclusions and justification for the CAPAs
- collate the evidence of the CAPAs implementation
- writing the audit response report
Validation & Qualification
Our consultants can guide you in the following validation areas:
- Pharmaceutical Process Validation
- Analytical Method Validation
- Pharmaceutical Cleaning Validation
- Equipment Validation
- Medical Device Sterilization Cycle Validation
- Clean room qualification
Solid Oral Dosage Forms Formulations
Within our team we have experts with over a decade of experience in the development of formulations for solid oral dosage forms. Whether it is a conventional release tablet, controlled release tablet, enteric coated tablet, granules, granules within a hard shell capsule or normal hard shell capsule dosage form, we can assist during the development process or if a particular product in commercial production is troublesome and in need of improvement. The latter is subject to submission of a variation to the common technical document (CTD or dossier) of the commercial product.
If you are interested in reducing waste within your operational activities we can conduct an audit of your processes with the scope of identifying steps that can benefit from the application of the lean philosphy.
The original seven wastes (or muda) as defined by Toyota are the following:
- Transport (moving products that are not actually required to perform the processing)
- Inventory (all components, work in process and finished product not being processed)
- Motion (people or equipment moving or walking more than is required to perform the processing)
- Waiting (waiting for the next production step, interruptions of production during shift change)
- Overproduction (production ahead of demand)
- Over Processing (resulting from poor tool or product design creating activity)
- Defects (the effort involved in inspecting for and fixing defects)
During our audit we will observe your operations to identify "wastes" with the aim to improve productivity, decrease defects and ultimately improve the bottom line of the operations.
New facility start-up
If you are planning to set-up a new manufacturing or contract analysis lab in Malta we can offer the possibility to act as a representative with local authorities as well as related service providers. We can organize meetings with the local regulatory authority (Malta Medicines Authority), Malta Enterprise, Malta Industrial Parks, equipment suppliers, contract laboratories, companies providing financial auditing services, lawyers, Malta Financial Services Authority, local banks and other parties as you deem necessary.
Contact Us to ask for a quotation or if you would like to know more about our services.