The document defines a Pharmaceutical Quality System (PQS) and describes the PQS implemented at the Ninewells Aseptic Dispensing Unit. A PQS is the organized system that ensures medicinal products are of the required quality. The Ninewells unit prepares 38,000 items annually using isolators and laminar flow cabinets in grade B and C rooms. Key elements of its PQS include documentation control, standard operating procedures, change control, deviation management, personnel training, internal auditing, complaints handling, and quality reviews. However, a formal validation master plan is not currently in place.

1. Simbarashe Mavhunga
Senior 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?

2. • Aseptic Processing
The 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.
• Risk
The 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 Management
The systematic application of quality management policies, procedures, and
practices to the tasks of assessing, controlling, communicating and
reviewing risk. (ICH 2005)
• Quality
The totality of features and characteristics of a product or service that bears
its ability to satisfy stated or implied needs.
• Quality Assurance
The 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 Management
The 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.
• Pharmaceutical
A compound manufactured for use as a medicinal drug.
• System
A 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

3. 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.

4. 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.

5. • 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

6. PQS House Model

7. 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)

8. Ninewells Aseptic Dispensing Unit
Organisational Structure

9. • 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

10. • Change Control
A 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 policies
An 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

11. • 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

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