+632-8293 7151 / +632-8293 7152
QUALITY ASSURANCE
Scheele’s Pharmaceutical Quality Management System (QMS) & its Main PQS Department
Scheele Laboratories Phils., Inc. (Scheele) follows a series of globally recognized standards. These standards guide the establishment and functioning of Quality Management Systems (QMS) to ensure that all its products are safe, reliable, and of the highest quality. The Department handling the QMS / PQD basically provides assistance to top management in the establishment, implementation, maintenance and continual improvement of Scheele’s PQS. Some of the key industry standards that Scheele integrated into their QMS framework, and part of the Integrated Management System Framework, are:
Scheele’s Commitment to Continuous Improvement and Upholding of the Highest Quality Standards
The essence of a QMS revolves around a continuous cycle of improvement and reassessment, which is integral to the dynamic and highly regulated pharmaceutical landscape. It involves various components such as Good Manufacturing Practices (GMP), documentation, risk management, and, importantly, Corrective Actions and Preventive Actions (CAPA). In essence, Scheele’s QMS is not just about compliance; it’s a tool that fosters excellence, transparency, and accountability, driving the production of high-quality pharmaceuticals.
Likewise, the QMS of Scheele created and monitored high-quality practices during all phases of the product life cycle, including production and testing, and these, in turn, comprised all the significant phases of drug production, such as Drug Formulation, Method development, etc…
As a whole, Scheele significantly considers that QUALITY is one of the most important management principles of a pharmaceutical manufacturing company, such as itself, and that this attribute must be upheld in the highest order.
QUALITY CONTROL
Scheele Laboratories Phils., Inc. – Quality Control Department
Quality Control (QC) in Scheele Laboratories Phils., Inc. (SLPI) has deemed critical its goals, objectives & endeavors, significant to the safety, efficacy, and consistency of all its current line of pharmaceutical products. Most are relative to known processes involved in the rigorous testing, inspections, and compliances with regulatory standards to detect and/or prevent defects or deviations in the manufacturing processes at Scheele Laboratories.
The Quality Control Department at Scheele has set its role within the company with the main intention as to verify and test its drug product(s) at various stages of production to ensure that every product is of the highest quality. The Quality Control section of Scheele likewise encompasses identifying product defects and fixing these problems with corrective techniques and measures.
Scheele Laboratories Phils., Inc. – Commitment to Continuous Improvement and Upholding of the Highest Quality Standards
The Quality Control department of Scheele Laboratories inclusively encompasses a number of strengths, highlights, and/or, significant contributions to the development and growth of the company in these past years.
These draw attention to the following processes, to name a few of the critical ones:
(1) Dissolution Profiles – these delineate the rate and extent to which the active pharmaceutical ingredient (API) is released from its dosage form into the dissolution medium under standardized conditions; (2) Biowaiver Monographs – is a Biopharmaceutics Classification System (BCS)-based waiver monograph & is a regulatory option to substitute appropriate in vitro data for in vivo bioequivalence studies; (3) Method Development – is a vital step in pharmaceutical analysis as it plays a key role in drug development and quality control. This process involves selecting appropriate techniques and optimizing various parameters to ensure accurate and reliable analysis of pharmaceutical samples.
The Quality Control department likewise has included a number of Pipeline projects/Endeavors geared towards not only for the improvement of the department itself, but for the company as a whole. These are: (1) Alignment into the ISO 17025 Standard – This is an international standard for testing and calibration universally accepted within the pharmaceutical manufacturing industry. The standard enables Scheele Laboratories to demonstrate that the company can operate competently and able to generate trusted results, assist in mitigating laboratory risks, thereby leading to the enhancement of profitability of Scheele and likewise, improve customer satisfaction. (2) Laboratory Quality Management System (LQMS) – refers to a set of policies, procedures, and practices implemented in a pharmaceutical manufacturing company to ensure consistent quality and accuracy in its operations. The Quality control department has employed various standards and regulations which outline specific requirements for implementing a Quality Management System (QMS) in a drug manufacturing environment, such as ISO 17025:2017, etc…These internationally-recognized standards provide necessary guidelines and criteria for laboratory processes, which include testing, calibration, documentation, personnel competency, and overall quality control within the manufacturing setting of Scheele Laboratories.
Laboratory processes that require quality practices as covered by Scheele’s Quality Control department, include:
A significant aspect of quality control is the establishment of well-defined controls. These controls help standardize both production and reactions to quality issues. Notably, the quality control used in a pharmaceutical manufacturing arrangement is highly dependent on the product or the manufacturing industry itself. Specifically, in the pharmaceutical manufacturing industry, Quality Control includes ensuring that all finished products, in this case, drug preparations, must be of the highest quality, and must never cause any adverse consequence(s) on all its clientele or consumer, and that the Quality Control department must guarantee that the Scheele Laboratories Phils., Inc. must turn out drugs products which are all globally competitive,,, and manufactured utilizing internationally-accepted Q.C. standards.