documentation requirements & strategies for the ... · documentation requirements &...

Documentation Requirements &

Strategies for the Pharmaceutical

Quality System

PharmaQual 360º ConferenceFebruary 22, 2017

Chris Wubbolt

QACV Consulting, LLC

www.QACVConsulting.com 1

Objectives


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

Pharmaceutical Documentation &

Recordkeeping Requirements


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.

Pharmaceutical Documentation &

Recordkeeping Requirements


• Well structured and clear

• Facilitate common understanding

• Consistent application.

Documentation

• Organizational size and complexity

Organizational Considerations

Organizational Size and

Complexity


• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

Current Regulatory Requirements

and Guidance


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.

Organizational Size and

Complexity Considerations


Size and Complexity

• Single site

• Multiple sites

• Corporate + Multiple Sites

• Multiple Sites in different countries/languages

• Acquisition/merger Transition

Multiple Sites


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

Multiple Sites / Multiple Languages


Transition


• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

• Policies

• SOPs

• Specifications

• Plans

• Protocols

• Reports

• Records

Considerations


• Consistent Quality System

• Consistent Quality Requirements

• Standard Processes

• Local site personnel must understand procedures (document translations)

• Corporate oversight, but site responsibility for compliance


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.

Quality System Documents


Quality Manual

Policies

SOPs

Forms / Templates

Records


QSD Structure

Corporate Policies

Quality Manual

Corporate SOPs Site Specific SOPs

Work Instructions

Standard Operating Procedures


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.

Considerations


• 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

Considerations


• Translations

• Adequacy of SOP

– Relates to level of detail

Three “A’s” of Quality

21 CFR 211


• 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.

Generalities


Buzz words

Typically

Normally

Usually

Generally

How do you determine adequacy?

Look for consistency / Inconsistency in

records


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


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.


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

Summary


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

Questions


Chris Wubbolt

QACV Consulting, LLC

Telephone: 610-442-2250

E-mail: [email protected]