Seqens eBook - 6

The Long Paper Trail
of Documentation in
API Manufacturing
Ed Price, CEO, Seqens CDMO North America
Documentation - and loads of it - is essential in API manufacturing if a
company wants to comply with current Good Manufacturing Practice
(cGMP), and eventually seek and obtain FDA approval.

So, who is responsible for developing all of this documentation? Typically,
the head of each manufacturing department or project is the one ultimately
responsible for developing, distributing, maintaining, controlling and
archiving all documentation for his/her respective projects.

During manufacturing site inspections, federal regulators spend a lot
of time reviewing a company's documents and records, so effective
documentation practices confirm its dedication to quality controls.

CMOs and other manufacturers are responsible for ensuring that all cGMP
activities are performed according to the company's clearly defined
Standard Operating Procedures (SOP). Any time those SOPs change, they
must be reported to management for proper implementation. When a
document has been revised, systems must be in place to ensure proper
version control.

So why all the paperwork? It's not only a requirement of the government,
to prove that a drug will be safe and effective for patients, but it also
provides a trail of best practices and a roadmap for future products for the
sponsoring company and its Contract Manufacturing Organization (CMO).

Below are key practices CMOs and other manufacturers can take to ensure
that documentation management happens more smoothly.

For companies documenting their cGMP compliance, it helps them ensure
and prove that products are consistently produced and controlled to the
quality standards appropriate for their intended use. cGMP regulations
require that the pharmaceutical manufacturer or CMO maintains proper
documentation and records, which helps to build up a detailed picture of
what was done in the past regarding a specific product and what is being
done now, to provide a basis for planning how to proceed in the future.

Follow written procedures. Document preparation, processing,
distribution and obsolescence practices need to be governed by carefully
defined written procedures.
Use multiple databases. CMOs need to have a sufficient way to control
complex documentation. They should use multiple databases to control,
track and cross-reference the company's SOP, employee training records,
material and manufacturing records and data. They can also be used to
track Preventative Maintenance (PM), equipment calibration, deviation
and quality investigations, Corrective and Preventative Actions (CAPA),
change control and employee training records.

The Various Types of Documents Required
for cGMP Compliance
cGMP-labeled manufacturing facilities must adhere to their own Quality
System's requirements for the design, format and organization of all their
internal documentation. To ensure that this is accomplished, below are
some of the most common types of documents that are required:

Document batch manufacturing reviews. When batch manufacturing is
complete, a quality assurance team should review and reconcile all issued
documentation to ensure the information is properly recorded. It also
should reconcile all issued documentation to ensure the information is
complete, after which they can securely archive the documentation.

Quality assurance documents. Outlines the company's own Standard
Operating Procedures (SOPs) and regulations.
SOP documentation. Provides step-by-step instructions for performing
each stage in a facilities operation.

Scan documentation. As an added measure, and to allow for rapid
retrieval of information, all original data and documentation should be
scanned into a digital format, and there are a number of off the shelf tools
available to do this.

Batch records. Outlines all the production-related tasks and activities Test
method documents. Provide step-by-step instructions for testing supplies,
raw materials, in process samples, final products and their corresponding
tasks and activities.

Conduct ongoing training. Finally, it's important to conduct ongoing
training of all staff to ensure continuous proper documentation practices.

Specifications listing. Outlines what is required of a product before it can
be released.

Documentation is a complex and time-consuming process, but a critical
element in the discovery, manufacture and delivery of drug products. The key
is establishing sound processes each step of the way to meet all the regulatory
requirements, cGMP guidelines and your own defined internal controls.

Logbooks. Documents all core activities, such as the operation,
maintenance, and calibration of equipment; or the quality of clean rooms,
solution preparation, etc.
Pharmaceutical Outsourcing |

6

| pharmoutsourcing.com



http://www.pharmoutsourcing.com

Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
Seqens eBook - 5
Seqens eBook - 6
Seqens eBook - 7
Seqens eBook - 8
Seqens eBook - 9
Seqens eBook - 10
Seqens eBook - 11
Seqens eBook - 12
Seqens eBook - 13
Seqens eBook - 14
Seqens eBook - 15
Seqens eBook - 16
Seqens eBook - 17
Seqens eBook - 18
Seqens eBook - 19
Seqens eBook - 20
Seqens eBook - 21
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Seqens eBook - 23
Seqens eBook - 24
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Seqens eBook - 27
Seqens eBook - 28
Seqens eBook - 29
Seqens eBook - 30
Seqens eBook - 31
Seqens eBook - 32
Seqens eBook - 33
Seqens eBook - 34
Seqens eBook - 35
Seqens eBook - 36
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