Introduction
In pharmaceutical sector
documentation system varies from company to company.
Pharmaceutical documentation
system can be divided into two functional classes for better understanding,
segregation and control:
- Product Documents
- Process Documents
Documents generated during the product
life cycle (ICH Q10). This category include product development
plan, developmental history reports, stability data, process validation data,
preclinical reports and data, clinical trial reports and data, drug master
files and dossiers, specifications (raw materials, intermediaries, finished
products, container closure system), batch manufacturing procedures and
records, batch testing procedures and records, Batch release records, batch
dispatch records, post marketing surveillance, market complaints, product
recall etc. For each product these documents are different and uniquely
identified based on product code.
The makeup of these documents is
defined by regulatory requirements for product & process and applicable GMP
requirements.
Support Process Documents:
These are the documents of
supporting processes required for proper product realization, quality
compliance, regulatory compliance and customer satisfaction. The makeup of
these processes may vary from organization to organization and are influenced
by organizational size and structure. These processes/departments include:
Human
Resource: Other than administrative function HR deals with the requirement of
personnel as per GMP guidelines. Human resource ensures that the personnel
performing work affecting the conformity to the product requirements shall be
competent on the basis of appropriate education, training, skill and
experience. They define job descriptions, job responsibilities and reporting
pattern for each post and individual. In some organizations (instead of Quality
Assurance) competence, training and awareness of the personnel are also
included in Human Resource functions.
Purchase:
Ensures that
the purchased product confirms to specified purchase requirements and necessary
resources are provided as per need and in time. These resources may include
infrastructure, work environment, raw materials etc.
Warehouse
and Dispatch: This process includes physical verification of
purchased product, its identification and traceability. Approved materials are
distributed for different product realization steps and their traceability is
maintained.
Production
(General): This includes operation and activities other than
product manufacturing activities which supports and ensures that the production
process is carried out as per GMP. This includes cleaning processes, facility
and equipment operation and maintenance, personnel and material flows, waste
disposal, biosafety, bio-security, containment, product changeover and campaign
change, equipment qualification and calibration etc.
Quality
Control: Testing and control procedures other than product testing. This includes
raw and packaging material, Environmental Monitoring, Water system testing,
Analytical Method validations, Microbiology, Good Laboratory Practices etc.
Quality
Assurance: Control and supervision of all the production,
testing and control activities. The process includes implementation of Quality
and QMS system in an organization as per regulatory guidelines and applicable
GMP standards.
Maintenance
and Engineering: Ensures that the plant, equipment and machineries
operate under total control and are maintained to minimize breakdown.
Equipments are qualified and maintained as per schedule. All the instruments
are calibrated as per defined frequency.
Documents of all the above
processes/ departments shall be identified with a unique identification number
to better control over documents.
| 4.2.2 | Quality Manual |
| 4.2.3 | Control of Documents |
| 4.2.4 | Control of Records |
4.2.2 Quality manual:
This Quality Manual is
prepared in line with the requirements of ISO 9001:2008. The Quality Manual supplemented by system
documents describes company’s QMS. The scope and permissible exclusions of the
QMS are described in section one (Scope) of this manual. Each section of the
manual references documented QMS procedures relating to the requirements
outlined in that section. The Process Flow provides a description of the
processes and interaction between the processes within QMS system.
4.2.3 Control of document:
(The brief policy
of the documentation control system shall be provided at this point.
Introduction to process wise or department wise segregation of the documents
practiced in the company can be provided.) For example:
For the purpose of control Documentation system is divided
into two sections:
Product
Documents
Support
Process Documents
(Description
of the sections can be given as above.)
(A detailed
description of document control procedure or just an overview may be given in
this paragraph.) Responsibility of document control
and management is shared between QA and owner department of the document. The
document control system is defined in SOP (cite
procedure reference no) and ensures that:
- Approve documents for adequacy prior to issue
- Review, update as necessary and re-approve documents
- Ensuring that changes and current revision status of documents are identified
- Ensure that relevant revisions of applicable documents are available at points of use
- Ensure that documents remain legible, readily identifiable and retrievable
- Ensure that documents of external origin are identified and their distribution controlled
- Prevent the unintended use of obsolete documents, and apply suitable controls and identification measures if they are retained for any purpose
4.2.4 Control of Quality Records
The records are maintained as per
SOP (cite procedure reference no) demonstrate
conformance to specified requirements and the effective operation of the
quality management system. The procedure specifies the methods for controlling
quality system records, defines internal requirements for record keeping and
requires that records are identified, collected, indexed, filed, stored and
maintained in a manner that provides assurance that they are retrievable when
required.
The records are also classified,
maintained and archived as per paragraph 1 of 4.2.3 Control of document.
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