Organization of
Documentation System
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Information Management
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Knowledge management
Whenever a new pharma/vaccine plant is being setup
Quality department is in utter mess when it comes to organization of the documentation system. There is no common
understanding on ‘what to document and
what not to document’. The reasons
for this problem are:
One:
they try to fit in a generic system (provided by a consultant or through the
documentation manager previous experience)
Two:
most of the staff is new to the system and cannot figure out where to start
Three:
documentation department is understaffed.
The result is too many
documents, no sequence in documentation matrix, too many draft printouts means
utter mess.
Process
approach is the best way out in such cases. Identify the
processes in an organization, prepare a process flow chart and identify
procedure requirement for each process based on this flow chart. Prepare a list
of documents using process flow chart and assign the responsibility for
preparation of documents. Prepare a separate review team for each process which
includes subject matter experts.
Another simple approach to organize a
documentation system is given below. The approach is based on 4Ms, P, E & QMS:
4Ms
: Man, Machine, Material,
Method
P : Product
E : Environment
QMS : Quality management
System.
MAN:
Prepare
an organogram
Define
Job description (consider requirements of Skill, Education, Training and
Experience for each position)
Prepare
procedure for training and qualification of personnel. Define training needs
for each JD
Prepare job
responsibility and Authority.
MACHINE:
Assign
Equipment Identification Numbers and Prepare a ID list
Identify
equipments based on Impact Assessment (Direct, Indirect, No impact)
Qualify
Equipments Based on above Impact Assessment (URS, IQ, OQ, PQ),
Identify
components of each equipment (Part Number or Tag Numbering System)
Classify
as Critical or Non Critical based on Impact Assessment
Prepare Operational
SOP.
MATERIAL:
Purchased Materials:
Materials purchase in any manufacturing unit can be classified into below given
categories:
- Asset
- Production Consumables
- Lab Consumables
- Engineering Items
- Plant Maintenance, Spare parts and Consumables
- Administration Consumables
- Fuels and Lubricants
- Services
These classes can be
assigned different code for identification or certain number system can be
reserved for each class.
Manufactured Materials:
there are the products manufactured. For better control they are divided into:
- Intermediates
- Drug Substance
- Drug Product
Material control has
uniform philosophy. We should have a material specification, material sampling
and testing plan, and material distribution traceability.
METHODS:
Here
we have used the term methods synonymously to Processes. Have a clear
understanding of a process (remember
Water generation and Distribution system is an equipment and Generation and
Distribution of Water is process, similarly autoclave is equipment and
sterilization is process). So the methods/processes can be
classified as:
- Manufacturing (validation included)
- Testing (validation included)
- Support
PRODUCT:
Product can only be
identified through records, so records generated during product realization fall
into this category. These records are Batch Manufacturing Records (BMR), Batch
Packaging Record (BPR) and Batch Testing Record (Analytical File).
ENVIRONMENT:
This is an added
requirement for pharma/vaccine manufacturers because manufacturing and testing
environment is an important contributor to product quality. Maintaining
required conditions require extensive setup and large number of equipments and
components (such as Clean Rooms, HVAC, BMS, Safety, Security, ETP etc). The
environment need to be monitored for its compliance and thus this category
includes all the environment control and monitoring procedures.
QMS:
It contains the
documents required for implementation of QMS and it continual improvement.
The above classification can be summarized in the following chart:
REGULATORY EXPECTATIONS
When we are preparing
the list as per above scheme we need to meet the regulatory expectation for documentation system. Regulatory
agencies have extensive requirement for documentation published as a part of GMP
requirements. Few are given below:
EudraLex Volume 4
Chapter 4: Documentation provides an extensive classification of documentation
requirement.
WHO’s Quality
assurance of pharmaceuticals, Vol 2 and Annex 2, WHO Technical Report Series
986, 2014.
ICH Q7 Section 6,
Documentation and Records.
FDA has in its CFR
Part 210 has laid down extensive documentation expectation which is highlighted
by the terms, ‘Documents’, ‘Written Procedures’, ‘Requests’, ‘Forms’,
‘Reports’, and ‘Records’.
Schedule M of Drug and
Cosmetic Act has made it clear in its first note and it states that, ‘To achieve the objectives listed below, each
licensee shall evolve appropriate methodology, systems and procedures which
shall be documented and maintained
for inspection and reference; and the manufacturing premises shall be used
exclusively for production of drugs 3[and no other manufacturing activity shall
be undertaken therein except in respect of units licensed prior to 11th
December, 2001]’.
ISO 9001:2008
in its clause 4 Documentation requirements Sub-clause 4.1 identified the
documents required as:
a) documented statements of a quality
policy and quality objectives,
b) a quality manual,
c) documented procedures and records
required by this International Standard, and
d) documents, including records,
determined by the organization to be necessary
to ensure the effective
planning, operation and control of its
processes.
WHAT NEXT
Once it is determined
what needs to be documented next question is how to document, what are
the good documentation practices?
As in pharma/biopharma
everything roots to Standard Operating Procedure, we need to know what an SOP is and how to prepare an SOP.
