With over 100 years of experience across our team, Zeta understands the timelines and difficulties clients face throughout the manufacturing process, including release and distribution. Our knowledge and expertise allow us to effectively meet your expectations and ensure that you and the QP are seamlessly prepared for the batch disposition decision.
Why Choose Zeta for QC Release Testing
At Zeta, we are passionate about providing comprehensive Quality Control (QC) testing services. We aim to deliver consistent, high-quality testing solutions and services for our clients. Our team is dedicated to upholding the highest standards of excellence, supported by our GMP certification and commitment to adhering to industry regulations and guidelines. We ensure that all testing conducted meets the highest quality and regulatory requirements.
Our Commitment to Quality
GMP Certification
As a GMP-certified laboratory, we adhere to the stringent quality control principles and regulatory guidelines of the MHRA to ensure the integrity of pharmaceutical testing. Our procedures keep us compliant with all guidelines, maintaining meticulous documentation, instrument calibration, and quality control procedures to uphold the highest standards of analytical excellence.
Robust QA Practices
Our dedicated Quality Assurance (QA) team meticulously monitors all testing processes, from sample preparation to analysis and reporting, to guarantee accuracy, reliability, and compliance with industry standards. Our software documents all stages of testing, from the initial weighing of samples to the calculations of results.
Comprehensive Testing Capabilities
Finished Products
We offer comprehensive QC testing for finished pharmaceutical products to verify potency, purity, and quality, ensuring compliance with regulatory specifications and label claims. At Zeta, we are currently testing over 150 generic drug molecules and managing over 2000 different testing specifications.
Stability Testing
We execute stability testing to evaluate the shelf-life and storage conditions of pharmaceutical products. This ensures products maintain potency, purity, and quality over time.
Raw Materials Testing
Our analysts can carry out all required testing for your needs, whether it be APIs or intermediates. Our testing can determine the potency and purity of the compounds and ensure they fall within specifications.
Blend Formulations
We have incredible experience analysing blend formulations to verify uniformity, homogeneity, and consistency, ensuring optimal drug delivery and performance.
Cleaning Validations
We provide comprehensive cleaning validation services to verify the effectiveness of cleaning procedures and ensure the absence of residual contaminants in manufacturing equipment and facilities. Our methodology allows us to detect many compounds at various ranges from as low as ten ppm.
In-Vitro-Dissolution Profiling
To compare the bioequivalence and bioavailability of proposed formulations with marketed products, Zeta offers comprehensive in-vitro dissolution profiling services. Ensuring the tested material meets regulatory requirements and industry standards.
Customised Solutions and Timely Results
Tailored Testing Protocols
Our experienced scientists work closely with clients to develop customised testing protocols tailored to their needs, requirements, and regulatory obligations.
Timely Reporting
We understand the importance of timely results in the pharmaceutical industry. Our efficient testing processes and dedicated team ensure prompt reporting and delivery of accurate analytical data to support decision-making and regulatory submissions. Our reports can be catered to clients' specific requirements. If testing needs to be completed urgently, Zeta offers an expediting service to ensure reports are released as soon as possible.
Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigations
Expert Analysis
In the event of an Out-of-Specification (OOS) or Out-of-Trend (OOT) result, our experienced team conducts thorough investigations to identify root causes, assess the impact on product quality, and recommend corrective and preventive actions.
Regulatory Compliance
We ensure that all OOS and OOT investigations are conducted in accordance with regulatory requirements, including proper documentation, reporting, and communication with regulatory authorities as necessary.
At Zeta Analytical, we are committed to delivering exceptional QC testing services that instil confidence, promote regulatory compliance, and contribute to the success of our clients' pharmaceutical products and operations.