What Quality means to Fresenius Kabi Oncology Limited

The commitment to improving a patient’s quality of life is invaluable to Fresenius Kabi Oncology Limited. Therefore, the Company adheres to effective Quality Management procedures in order to ensure high level of safety and efficacy in our products. Our manufacturing operations follow the cGMPs and all other necessary certifications and guidelines to maintain total compliance with Pharmaceutical Regulatory Authorities’ norms and thereby meeting the expectations of our partners and customers.

With the aim to assist the medical professionals in providing the best possible therapy and care for cancer patients globally, we consistently thrive for continuous quality improvement across all areas in our operations.

At Fresenius Kabi Oncology Limited, we try to ensure that every individual accepts to thrive for continuous improvements over our systems and processes as their goal. Also, effective decision-making based on the analysis of data and information is an important aspect of our operations management.

Our commitment to continuously offer products and services with high quality and efficacy is the foundation of our long-lasting and successful partnerships with our customers. Therefore, according to the international ISO-9001 Standards, our quality management system is regularly reviewed during internal quality audits and certified by external auditors.

Good documentation is an essential part of the QM System and is a prerequisite for compliant operations. Generally, there are two primary types of documentation:

a) Instructive documents which define and direct all quality impacting activities like e.g., Handbooks, SOPs, Guiding Documents, Working Instructions, test plans, sampling plans, templates and

b) Records or reports that document the execution of those activities (e.g., manufacturing and laboratory testing records, audit reports, validation reports, batch records, sampling records, etc.).

The instructive global QM Documents are made available to all parties involved in electronic format. Information on new or revised global QM Documents is actively communicated.

Upon receipt, the recipient has the responsibility to assess new or revised QM Documents for applicability to their products, systems, processes and business operations.

If applicability is identified, the respective QM Documents are implemented effectively into the local QMS.

 

                                  Quality Management Documents Structure

(Quality) records provide documented evidence of the execution of quality impacting activities (e.g., batch protocols, audit reports, delivery notes, purchasing reports, validation documentation, raw data in production and quality control, maintenance documentation, calibration protocols, customer visit reports, user training records, etc.).

In line with Data Integrity and Good Documentation Practices, the recorded data follows the ALCOA+ principles:

ALCOA

§  Attributable (traceable, (electronically) signed or authorized and dated (timestamped).

§  Legible (readable, permanent, unambiguous).

§  Contemporaneous (recorded promptly).

§  Original (or a true copy).

§  Accurate (correct/truthful & complete).

 ALCOA PLUS (+)

§  Complete – Data includes all data, including metadata and edits.

§  Consistent – Data is created in a repeatable and comparative manner.

§  Enduring – Stored on media proven for the record retention period.

§  Available – readily accessible in human readable form for review throughout the retention period for the record.

Any alteration made to a record is signed and dated; the alteration permits the reading of the original information. The reason for the alteration is recorded. Critical GxP relevant data in computerized systems require the establishment of audit trails.

Records may exist in paper or in electronic from. As a minimum requirement, records are:

§  Clearly identifiable (specific document number or title).

§  Dated, paginated, version controlled where required.

§  Signed or authorized by author.

§  Approved.

§  Traceable & retrievable.

Originals of QM Documents are archived in accordance with the respective legal requirements. Electronic data is archived in a way that prevents manipulation, ensures readability, data security and integrity and complete retrievability.

EHS Policy