Agentes Da Saúde

Cleaning & Sanitization

Standard: Cleaning and/or sanitization (C&S) must be performed in all manufacturing

and GTC pilot plant facilities to minimize physical, chemical and/or

microbiological contamination with the purpose of meeting applicable

regulatory requirements, enhancing operational efficiencies, and protecting

our products, assets and equities. Data to assess the effectiveness and

efficiency of the site C&S program to drive continuous improvement must be

utilized.

1. Ensure qualified personnel lead the local C&S program. The site C&S

Management Steering Committee, C&S Team and C&S Focus Factory

Area Team(s) must be formed and documented as stated in Quality

SOP 20432.

2. Provide training on C&S as listed in Quality SOP 20432.

3. Develop a full site C&S program based on Quality SOP 20432

(Attachment Exhibit Form 8.1.1. - C&S Program Road Map). The

program must demonstrate effective removal of chemical, physical, and

microbial contaminants.

4. Ensure the design and/or installation of new and/or used equipment is

per the C&S Guidelines (GL). Existing equipment and equipment

undergoing significant modifications as determined by the site change

control documentation (Quality Standard 031) must be evaluated using

the equipment assessments listed in GL # 3. The appropriate corrective

actions must be taken and documented. Requirement details are listed

in Quality SOP 20432.

5. Continuously improve the C&S program by using the C&S Guidelines,

Guidance Documents, Control Point Monitoring (CPM), C&S Website

and assessment tools summarized in Quality SOP 20432.

For each of the above, ensure that procedures are documented and

effective.

Scope:

This standard applies to all areas of the supply chain and technology

where C&S is performed. Facilities are expected to conform to this

Performance

Expectations:

Quality Standard: 045 Cleaning & Sanitization

2010-045-00 – December 17, 2010 Page 3 of 7

standard by developing a complete C&S program. They are also

expected to use the risk based assessment tools highlighted in

Quality SOP 20432 to determine priorities and implement plans to

close gaps in their programs.

Responsibility: Site Manufacturing Leader: Ensures that the appropriate organization,

resources, and verified procedures are in place to adequately implement

the entire C&S program including the assignment of roles and

responsibilities and waste minimization in CP Facilities.

Site C&S Management Steering Committee: Provide guidance on

scheduling