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Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360 º Conference February 22, 2017 Chris Wubbolt QACV Consulting, LLC www.QACVConsulting.com 1
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Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Apr 06, 2018

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Page 1: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Documentation Requirements &

Strategies for the Pharmaceutical

Quality System

PharmaQual 360º ConferenceFebruary 22, 2017

Chris Wubbolt

QACV Consulting, LLC

www.QACVConsulting.com 1

Page 2: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Objectives

www.QACVConsulting.com 2

Review pharmaceutical documentation and recordkeeping requirements

Understand factors necessary to develop and implement a robust documentation management program

Understand key controls necessary to maintain documentation in a compliant manner

Optimize documentation management practices

Page 3: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Pharmaceutical Documentation &

Recordkeeping Requirements

www.QACVConsulting.com 3

ICH Q10, Pharmaceutical Quality System

• The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to facilitate common understanding and consistent application.

• The size and complexity of the company’s activities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one.

Page 4: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Pharmaceutical Documentation &

Recordkeeping Requirements

www.QACVConsulting.com 4

• Well structured and clear

• Facilitate common understanding

• Consistent application.

Documentation

• Organizational size and complexity

Organizational Considerations

Page 5: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Organizational Size and

Complexity

www.QACVConsulting.com 5

• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

Page 6: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Current Regulatory Requirements

and Guidance

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ICH Q10, Pharmaceutical Quality System

• While some aspects of the pharmaceutical quality system can be company wide and others site specific, the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level.

Page 7: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Organizational Size and

Complexity Considerations

www.QACVConsulting.com 7

Size and Complexity

• Single site

• Multiple sites

• Corporate + Multiple Sites

• Multiple Sites in different countries/languages

• Acquisition/merger Transition

Page 8: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Multiple Sites

www.QACVConsulting.com 8

Site A

Site B

• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

Site C

• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

Corporate

Page 9: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Multiple Sites / Multiple Languages

www.QACVConsulting.com 9

Page 10: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Transition

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• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

Page 11: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Considerations

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• Consistent Quality System

• Consistent Quality Requirements

• Standard Processes

• Local site personnel must understand procedures (document translations)

• Corporate oversight, but site responsibility for compliance

Page 12: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

www.QACVConsulting.com 12

ICH Q10, Quality Manual

Description of the pharmaceutical quality system, including:

• Quality policy

• The scope of the pharmaceutical quality system.

• Identification of processes, including:

• Sequences

• Linkages

• Interdependencies.

• Management responsibilities.

Page 13: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Quality System Documents

www.QACVConsulting.com 13

Quality Manual

Policies

SOPs

Forms / Templates

Records

Page 14: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

www.QACVConsulting.com 14

QSD Structure

Corporate Policies

Quality Manual

Corporate SOPs Site Specific SOPs

Work Instructions

Page 15: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

www.QACVConsulting.com 15

QSD Structure

Corporate Policies

Quality Manual

Corporate SOPs Site Specific SOPs

Work Instructions

Page 16: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Standard Operating Procedures

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Procedures for Operating

in a Standard Manner

“Procedures” are referenced 72 times

in 21 CFR 211

It takes time to develop a Quality System.

It takes just as much time to maintain a Quality System.

Page 17: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Considerations

www.QACVConsulting.com 17

• Level of Corporate Oversite

• Governance between Policies / SOPs

• Level of Detail within SOPs

– How many pages?

• Each SOP requires:

– Review and approval

– Training

– Periodic Review

– Change Control

Balance initial effort to

develop Quality System

against sustainability

Page 18: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Considerations

www.QACVConsulting.com 18

• Translations

• Adequacy of SOP

– Relates to level of detail

Three “A’s” of Quality

Page 19: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

21 CFR 211

www.QACVConsulting.com 19

• Sec. 211.67 Equipment cleaning and maintenance.

• (b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:

• (1) Assignment of responsibility for cleaning and maintaining equipment;

• (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

• (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

• (4) Removal or obliteration of previous batch identification;

• (5) Protection of clean equipment from contamination prior to use;

• (6) Inspection of equipment for cleanliness immediately before use.

• (c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in 211.180 and 211.182.

Page 20: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Generalities

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Buzz words

Typically

Normally

Usually

Generally

How do you determine adequacy?

Look for consistency / Inconsistency in

records

Page 21: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

www.QACVConsulting.com 21

21 CFR 211

• The responsibilities and procedures

applicable to the quality control unit shall

be in writing;

– such written procedures shall be followed.

• Written procedures shall be established

and followed

Page 22: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

www.QACVConsulting.com 22

Adequacy

• Many SOPs are inadequate or do not provide

sufficient instruction to allow personnel to be in

compliance. For example,

– SOP-XXX, Line Clearance and Cleaning

• SOP requires visual inspection, removal of materials,

cleaning of ceiling, walls, floor, tables, chairs, bench,, pass

through, and windows.

• FRM-YYY, Line Clearance Log requires documentation of

visual inspection, removal of materials, cleaning of ceiling,

walls, floor, tables, chairs, and bench.

Page 23: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

www.QACVConsulting.com 23

Document Management Systems

• Document Attributes

– Carefully select attributes

• Approval – electronic or handwritten

• Templates

– Standard structure and format

• Forms

– Required information

• Document Change Control

– Impacted documents

Page 24: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Summary

www.QACVConsulting.com 24

Review pharmaceutical documentation and recordkeeping requirements

Understand factors necessary to develop and implement a robust documentation management program

Understand key controls necessary to maintain documentation in a compliant manner

Optimize documentation management practices

Page 25: Documentation Requirements & Strategies for the ... · Documentation Requirements & Strategies for the Pharmaceutical Quality System PharmaQual 360ºConference February 22, 2017 Chris

Questions

www.QACVConsulting.com 25

Chris Wubbolt

QACV Consulting, LLC

Telephone: 610-442-2250

E-mail: [email protected]