Simbarashe MavhungaSenior Pharmacist Aseptic Dispensing Service

28th November 2016

AN ASEPTIC UNIT SHOULD HAVE A COMPREHENSIVE AND CORRECTLY IMPLEMENTED

PHARMACEUTICAL QUALITY SYSTEM (PQS)

Define what a PQS is and Describe the PQS in place at Ninewells Aseptic Dispensing Unit?

• Aseptic ProcessingThe manipulation of sterile starting materials and components in such a way that they remain sterile and uncontaminated whilst being prepared for presentation in a form suitable for administration to patients.

• RiskThe combination of the probability (likelihood) of occurrence of harm and the severity (consequence) of that harm (based on ISO/IEC Guide 51) (ISO 2014). (ICH 2005).

• Risk ManagementThe systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk. (ICH 2005)

• QualityThe totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.

• Quality AssuranceThe maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

• Quality ManagementThe act of overseeing all activities and tasks needed to maintain a desired level of excellence. This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement.

• PharmaceuticalA compound manufactured for use as a medicinal drug.

• SystemA set of principles or procedures according to which something is done; an organized scheme or method.

• Good Manufacturing Practice (GMP) A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Glossary/ Definition of Terms

Developments in EU Good Manufacturing Practice (GMP) (EC 2015) have highlighted the need for a robust Pharmaceutical Quality System (PQS) (ICH 2008). Anyone preparing medicines should embrace the concept of Quality Management.

Pharmaceutical Quality System (PQS)A wide-ranging concept, which covers all matters that individually or collectively influence the quality of a product. Therefore PQS is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

• The design of the PQS should reflect the size and complexity of the preparation activities and should incorporate risk management principles.

• The PQS should be fully documented, for example in a quality manual, and its effectiveness monitored.

• The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels  to implement, maintain  and continually improve its effectiveness. 

PQS Design and General Principles

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Pers

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Docu

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Management of Outsourced ActivitiesValidation Master Plan

Quality Aspects of Product Lifestyle

Inte

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Aud

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Deviation Management

Pharmaceutical Quality Systems

PQS House Model

Quality ReviewProduct Recall Complaints

Pharmaceutical Quality System Present in the Ninewells Aseptic Dispensing Unit

• Approximately 38,000 aseptically dispensed items are prepared annually within Aseptic Dispensing Unit.

• 15.3 WTE staff required to operate the service safely.

• Facilities

• 2 x 2 glove negative pressure isolator in grade B room (cytotoxic preparation)

• 2 x Horizontal laminar flow cabinet in grade B room (PN preparation)

• 1 x 2 and 1 x 4 glove positive pressure isolator in grade C room (CIVAS)

• 1 x 2 glove negative pressure isolator in grade C room (cytotoxic preparation)

Ninewells Aseptic Dispensing Unit Organisational Structure

• Quality aspects throughout the product lifecycle.Product Initiation – Risk Assessment done using tool   developed by ASSIG/SPQAG as detailed in National Standard Operating Procedures

(NSOPs). This takes into account the Capacity Plan.• Documentation Control Systems

All aseptic documentation  is written and approved, following the "Writing and Approving  Aseptic Documentation" National Standard Operating Procedure, by

Pharmacy staff authorised to write and approve documentation and who are familiar with the  processes involved.  

• Standard Operating Procedures (SOPS)   The Aseptic Dispensing Unit uses a combination of NSOPs and Local work Instructions in cases where there is a slight variation in practice from NSOPs. All SOPS are on QPULSE.  

Pharmaceutical Quality System Present in the Ninewells Aseptic Dispensing Unit

• Change ControlA robust system for documenting and approving all planned changes (both

temporary or permanent) is present. All changes are evaluated for their potential impact on product quality, and a decision made on whether or not

to implement them.• Deviation Management, planned and unplanned

Planned deviations are managed via change control procedures, while unplanned deviations are investigated by completing a non conformance

report whereby a root cause analysis has been conducted. Corrective and /Preventative Action (CAPAs) are identified in this process.

• Personnel and training policiesAn approved and current training programme is available. Completion of training is documented in individual training records for all staff. Directly Observed Procedures method is used in the department and has proven

effective.

Pharmaceutical Quality System Present in the Ninewells Aseptic Dispensing Unit

• Internal audit 2 yearly audits are conducted as per comprehensive programme with Tayside

Pharmaceuticals Quality Assurance department. • Complaints and Product Recall

Complaints are handled as per the NHS Tayside Local policy. A mechanism is in place for recalls to Area Pharmacy Procurement Office (APPO). The Accountable Pharmacist or the

deputy shall discuss the appropriate action to be taken with the patient’s Clinical Pharmacist.

• Validation Master Plan (VMP)Currently there is no official VMP in the Ninewells Aspect Dispensing Unit. Due to logistical issues with integrating the data. Validation Data is kept by the QA department at Tayside

Pharmaceuticals.

• Quality Review No formal structures in place at the moment to conduct these reviews, however

there is a close working relation with the senior management and aseptic dispensing services.

Pharmaceutical Quality System Present in the Ninewells Aseptic Dispensing Unit

Thank You

"Quality is doing the right thing when no one is looking." - Henry Ford