Health regulators expect drug manufacturers to consistently and predictably make medicine with a high degree of quality. Needing to operate in a state of control, companies are expected to create and maintain robust processes and procedures for controlling manufacturing in their facility according to standards and guidelines laid out by their local health agencies.

Our trained consultants help clients answer important questions. Are your quality systems effective and robust? Do they follow the current guidance? Would inspectors agree that you are operating in a state of control?

Characteristics of an effective Quality Plan include:

• Strong, responsible, and independent Quality Assurance site management

• Transparent communication of quality issues within the whole organization

• Willingness and responsiveness to fix said issues

• An environment of continuous process improvement

QualiCeutics has experience evaluating and improving processes that fall under your Quality System umbrella. Some examples include:

Health inspectors continue to focus their attention on Data Integrity when auditing a manufacturing site. Many companies are now facing large fines and bans on imports due to poor electronic data handling practices discovered by these inspectors. In some cases, recorded data has even been knowingly falsified.

In most cases, companies unintentionally put themselves at risk by continuing to rely on paper documentation while simultaneously generating electronic records. If you are at risk for failing this sort of audit, trust QualiCeutics – we know how to build robust practices around data integrity.

Manufacturers use many computerized systems to produce and test medicines, and the electronic records created by these systems must be controlled. This is especially true in the QC Laboratory, where Chromatography Data Systems create thousands of files. The processes used to manage these systems are more complicated than paper records and require a thorough understanding of the regulations.

You need to ask yourself the following questions regarding your control of computerized systems:

• Are there formal processes in place to control username and passwords?

• Do user privileges prevent or track multiple changes to chromatographic test data? Are procedures in place to control chromatographic integration practices?

• Are sufficient audit trails in place?

• Is the data adequately backed up and maintained?

• Is all data traceable and available for an inspector to review, if required?

• Are instrument reports set up properly?

We know the systems and processes required to assure each client creates, modifies, and maintains controlled data. It’s extremely important to be proactive when dealing with data integrity.

Contact QualiCeutics to perform a deep-dive assessment into your data handling practices. Let us leave you confident that your electronic records are consistently authentic, traceable, and secure.

Laboratory Compliance is a core strength at QualiCeutics. We’ll go to great lengths making sure your Quality Control unit is operating in an up-to-date, inspection-ready environment, ensuring all test data meets the quality requirements and supports the manufacture of safe products.

Some of our laboratory consulting services include:

• Laboratory Investigations

• Good Chromatographic Practices

• Instrument & Equipment Qualification

• Good Documentation & Data Review Practices

• Training & Skill Assessment

• Standard & Sample Chain of Custody

Consultants from QualiCeutics have a broad knowledge base of the types of equipment and instruments used in pharma manufacturing and testing. Our expert consultants know the formal processes necessary to integrate and maintain a fully functional metrology program at your site. Our consulting expertise is broad, but we will tailor programs to fit the specific needs of your organization.

Any computer system used in the manufacturing or testing of pharmaceuticals must be validated or qualified. Custom programing or configuration settings must be proven to work. Computer System Validation (CSV) is a formal process used to verify that a computer and software application is installed, functions as intended and is controlled in a reproducible way.

QualiCeutics has successfully led or participated in the installation and validation of several types of complex enterprise systems used by Quality Assurance and Quality Control, including:

• LIMS – Laboratory Information Management Systems

• CDS – Chromatography Data Acquisition Systems

• EDMS – Electronic Document Management Systems

Often overlooked are the local, non-networked computerized laboratory systems. Our consultants have assessed many QC instrument types using GAMP principles and can provide recommendations to include in your next quality improvement program.

Some CSV expertise include:

• Project Management and Planning

• Process Mapping

• Gap Assessment with 21 CFR Part 11 regulations

• Supplier/Vendor Audits

• User Requirement Specifications

• Setting Functional Specifications & Acceptance Testing

• Data Migration and Report Verification

• Installation, Operation and Performance Qualification (IQ, OQ, PQ)

• Protocol Generation and Execution

• Training for Go-live

• Periodic System Reviews and Report Optimization

QualiCeutics consultants are experienced when it comes to project management, and have a detailed understanding of the pharmaceutical development and regulatory submission processes.

Under our leadership, organizations have learned how to successfully deliver technical transfer projects for manufacturing processes and analytical method transfer activities. Our expertise also includes managing the introduction and integration of electronic Quality Systems throughout your organization.

Let us help plan and implement your next process improvement project, where you’ll be left confidently operating in a compliant environment while consistently meeting, or exceeding, the expectations of health inspectors.

Be inspection ready. When practiced correctly, this often overlooked process can offer insight into the strengths and weakness of a manufacturing site. QualiCeutics can help prepare your organization for your next Pre-Approval Inspection by performing in-depth data reviews of:

• Quality (CMC) Submission Packages

• Batch Records

• API and Drug Product Stability Profiles

• Method Validation Reports

• QC Release Data

We can also perform mock audits of select departments and staff, in advance of an unannounced inspection, to gauge how well your Quality Systems meet the compliance standards. Take every advantage available and optimize your inspection-and-submission readiness. Get your team prepared with our help.

Current Good Manufacturing Practice (cGMPs) always include a training component, and companies seemingly meet this requirement. Unfortunately, most organizations do not have a robust or effective enough training program and practices are not typically harmonized at the site. Many programs are informal and administered by staff who have not been routinely supported, resulting in training that offers little value.

At QualiCeutics, we believe a vigorous training program is the most effective way to build a culture of quality at your organization. We have experience designing effective training programs, including:

• Curriculum Development

• Training Modules

• Training Material (like Instructor Guides & Student Guides)

• Proficiency Tests

• Integration with Learning Management Systems

• Classroom Training Sessions

So talk with us today about creating a powerful training program that will make a major difference for your organization.

QualiCeutics has experience writing clear and concise technical documents that will help minimize errors and pass the rigors of the inspection and submission processes. Contact us to help write your technical documents, including:

• SOPs (Standard Operating Procedures)

• Technical Protocols & Reports

• Test Method Validation reports

• Stability Reports