‘what to document & what not’

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.