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Document /Version: QM/01 ABC CO., Ltd.

Effective Date: 9 May 2006


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QUALITY MANUAL
Function: Quality Assurance Department Effective Date: 9 May 2006
Title: Quality Manual
Document: QM Version: 01
Replaces: N/A Next Review Date: 9 May 2008
Reason for Change: First Issue
Prepared by:
[Title]
Date:
Reviewed by:
[Title]
Date:
Approved by:
[Title]
Date:
Copy No: Issued to:
Distribution:-
XXX Department: Managing Director
XXX Department: Head of XXX
XXX Department: XXX Manager
XXX Department: XXX Manager
Document /Version: QM/01 ABC CO., Ltd.
Effective Date: 9 May 2006
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TABLE OF CONTENTS
SECTION TITLE PAGE ISO 9001
CLAUSE
ABC Quality Policy Statement 3
1 Introduction 3
2 Organization 3
3 Manufacturing Facility 4
4 Quality System 4
5 Management Responsibility 5
6 Design and Change Control 5
7 Document Control 5
8 Purchasing and Vendor Assurance 6
9 Material and Product Identification and Traceability 6
10 Process Control Programmes 6
11 Inspection and Testing Programmes 6
12 Calibration Programmes 7
13 Inspection and Test Status 9
14 Control of Non-Conforming Product 9
15 Corrective and Preventive Action Systems 9
16 Handling and Storage of Materials and Products 10
17 Control of Quality Records 10
18 Internal Quality Audits 11
19 Training Programmes 12
20 Statistical Techniques 12
21 Computer Systems Management 13
22 Facility Control 13
23 Management of Equipment and Critical Process Utilities 14
24 Validation Programmes 15
25 Occupational Safety and Health Programmes 16
Document /Version: QM/01 ABC CO., Ltd.
Effective Date: 9 May 2006
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ABC Quality Policy Statement
1. Introduction
1.1 Purpose of Quality Manual
The purpose of this Quality Manual is to outline the Quality Management Systems
used by ABC Co., Ltd. to manage the quality of its products. ABC business is the
manufacturer and sales of a range of products including medicines and cosmetics.
1.2 Scope of the Quality Manual
This manual covers the quality system that ABC has in place for the commercial
supply of its products. It refers to supporting documentation, procedures, quality
plans and work instructions associated with the manufacture, storage and
distribution of product.
2. Organization
Managing
Director
QA
Manager
Production
Manager
Engineering
Manager
Regulatory
Manager
Personnel
Manager
Financial
Manager
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3. Manufacturing Facility
3.1 Premise
ABC Co., Ltd. is located at XXX. The facility consists of XXX.
The Company is licensed by Thai FDA under GMP Certificate No. XXX with a valid date
from XXX to XXX to manufacture of XXX.
Manufacturing area and packing area where products expose are controlled to comply with
Class 100,000. The areas maintain their contamination control using a validated HVAC
system.
3.2 Equipment
All major pieces of equipment used in the GMP manufacture of the product should be
listed here, such as autoclaves, washers, bioreactors, chromatography systems.
All major pieces of equipment used in the QC lab to test raw materials, product or in-
process or environmental testing should be listed here, such as TOC, ELISA reader,
Spectrophotometer.
All major pieces of equipment in the Utilities should be listed here, such Purified Water
Systems, WFI generator, Clean steam generator.
4. Quality System
The Quality System ensures that the product complies with its specified requirements and
is manufactured in accordance with appropriate standards.
The Quality System is documented on four levels:
Level 1 Quality Policy
Level 2 Quality Manual
Level 3 Standard Operating Procedures
Level 4 Quality Records and Logbooks
The QA Manager (as a Management Representative) shall ensure that the Quality System
is being effectively implemented and maintained.
Quality Procedures (such as SOPs and Manufacturing Directions, Test Procedures) that
have been defined and documented are issued to all personnel listed in the controlled
distribution list and are used at the work place as references.
The QA Manager is responsible to liaise with the relevant departments to carry out the
following activities in order to meet necessary requirements for the products:
Preparation of various quality plans (including training, Quality Improvements)
Implementation and maintenance of GMP Quality System
Review of Quality System
Planning, scheduling and co-ordination of internal and external quality audits
Identification and preparation of quality records
The performance of the Quality Management System is examined at least once a year by
Management Review team which consists of XXX, XXX and XXX.
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5. Management Responsibility
The role of the Management team as well as the responsibilities and authorities are as
follows:
Managing Director is responsible for XXX.
QA Manager is responsible for XXX.
Production Manager is responsible for XXX.
XXX is responsible for XXX.
The Management team is clearly defined in with a view to:
Ensure approved procedures and instructions are adhered to in all facets of
production
Initiate action to prevent occurrence of product non-conformity
Identify and record any product quality problems
Provide solutions through designated channels
Verify the implementation of solutions
6. Design and Change Control
SOP XXX: Change Control
Change control is applied to the changes in design and facility.
Change control process begins with XXX,.
Flow chart of Change control is as follows:
7. Document Control
SOP XXX: Document Control
The Document Control Centre in Quality Assurance department is responsible for
controlling documentation and records.
The route of approval and issuing documents are as follows:
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8. Purchasing and Vendor Assurance
SOP XXX: Purchasing Procedure
SOP XXX: Vendor Audit Procedure
Quality of a pharmaceutical product depends as much on the quality of the raw materials
and equipment as it does on operations.
Therefore it is important that vendors and raw materials meet the required specifications.
An overview of the Quality Checks and procedures to ensure that the vendors meet the
specifications, such as audits, testing etc. are required.
Approved supplier list is defined and maintained.
9. Material and Product Identification and Traceability
SOP XXX: Lot Numbering System
All raw materials, packaging materials, and finished products are identified with a unique
code which described in the SOP XXX.
All unique codes that are used for the identification could provide full traceability.
Batch documentation
Traceability back to starting materials will be defined by Quality Assurance according to
regulatory requirements on Batch documentation, such that in the event of a product
recovery/recall that finished goods lots can be identified and retrieved.
10. Process Control Programmes
SOP XXX: Validation: Principles and Strategy
SOP XXX: Production Process Validation
SOP XXX: Analytical Method Validation
SOP XXX: Equipment Validation
SOP XXX: Cleaning Validation
SOP XXX: Computer Validation
All facilities, equipment and computer systems used for quality critical activities will be
suitably validated and records maintained of this validation.
11. Inspection and Test Programmes
11.1 Receiving Inspection and Testing
All materials and components supplied in accordance with a Purchase Order shall
be inspected on receipt for damage, completeness, identification and compliance
with the procurement documentation.
All materials and components shall be verified against the Delivery Order,
Specification Record, and/or Certificate of Analysis (C of A).
Selected incoming materials shall be tested as described in the Specifications
Record and Certificates of Analysis with specific batch test results obtained as
appropriate.
A QC Officer will perform sampling and testing if testing is required.
Rejected materials shall be returned to the supplier.
Materials and components meeting the specifications will be labelled with a
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"RELEASE" label and stored in the designated area under appropriate storage
conditions.
Materials and components rejected on receipt will be placed in a separate
quarantine area and identified accordingly, pending investigation
11.2 In-process Inspection and Testing
The QA Manager and the Production Manager shall ensure that in-process
inspection and test activities are carried out in accordance to the relevant SOPs
and master batch instructions.
These in-process tests are described in standard operating procedures and recorded
in production Batch Records and QC Test Records.
11.3 Final Inspection and Testing
The QC Manager will organise final quality control analysis on batch samples
according to specifications in Test Methods. The results of the tests shall be
recorded and retained.
If the results are not acceptable, the QA Manager will be responsible to activate a
non-conformance report.
All finished product lots are released based on verification of the validity of the
results and/or observation obtained from the in-process and final QC analysis.
Results are released by the QA Manager as per defined Standard Operating
Procedure.
12. Calibration Programmes
All measuring and test equipment and instrument used to demonstrate the conformance of
the product to specifications shall be of the appropriate precision and accuracy required for
the test, calibrated at appropriate intervals and maintained according to documented
procedures and a schedule.
Control of Inspection, Measuring and Test Equipment (Calibration) Proper and periodic
calibration ensures that the selected measuring equipment and instruments continue to
have the desired accuracy, and precision can be relied upon.
Calibration programmes ensure:
routine calibration is performed and completed according to written procedures
calibration of each measuring equipment and instrument is documented
specifications of accuracy and precision limits are provided
use of standards traceable to a national or international standard
remedial action is available to evaluate whether there was any adverse effect on the
product's quality. Remedial action includes recalibration and evaluation of the
impact of out-of-tolerance measurements.
Calibration Requirements
Analytical instruments in the Quality Control Laboratory are calibrated according to
published methods / procedures. These methods / procedures include specific directions
and limits for accuracy and precision. Routine calibration programme is carried out to a
schedule.
Measuring equipment and instruments associated with production and critical utilities in
manufacturing areas are calibrated according to published methods/procedures. These
methods/procedures include specific directions and limits for accuracy and precision.
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Routine re-calibration (performance check) programme are carried out according to a
schedule.
Calibration and Performance Check Records Calibrated equipment and instrument are
labelled to include:
equipment identification
calibration date
initial of the calibrator
date the next calibration is due
Calibration Schedules
Equipment and instruments are calibrated at periodic intervals established on the basis of
stability, purpose, and degree of usage of the equipment. Intervals between calibrations
can be shortened as required to assure prescribed accuracy as evidenced by the results of
preceding calibrations. Calibration is performed according to the frequency specified in
respective standard operating procedure.
13. Inspection and Test Status
Inspection and Test Status
Laboratory evaluation is performed to show with documented evidence that an incoming
material, intermediate or finished product was manufactured according to the Product
Specification. Finished product evaluation, as documented in standard operating
procedures, requires that the company establishes and maintains procedures for finished
product acceptance, to ensure that each production lot of finished product meets the
specifications stipulated in the Product Specification.
Finished products shall be held in quarantine or otherwise adequately controlled until
release.
Finished products shall not be released for distribution until:
activities required in the Master Batch Record (MBR) are completed
associated data and documentation is reviewed
release is authorised by signature of the Authorised Person
Change of Status and Location of Materials On receipt
Incoming materials are held in the quarantine receiving area until the documents have
been checked and the lot inspected. If there is a query or discrepancy they are held in the
quarantine area until the issue has been resolved. Finished product is held in quarantine
until released by the Quality Assurance Department.
Whenever a lot of material or finished product changes status it must be labelled with one
of the following status labels:
QUARANTINE (Lot under test not available for use or release)
RELEASE (Lot approved for use or release)
HOLD (Lot under investigation hold processing)
REJ ECT (Lot failed specifications not available for use)
If any lot does not have a status label it must not be used or released under any
circumstances.
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Authority to Change Status
Only authorised personnel are allowed to change status of any material, component and
bulk and finished product.
14. Control of Non-Conforming Product
All non-conforming materials and products shall be quarantined and investigated.
They will be properly identified, labelled, segregated, documented and evaluated for
appropriate action.
The control of non-conforming product procedure has been established to manage any
material and product that does not conform to specifications.
The procedure includes identification, documentation, evaluation, segregation, and
disposition of nonconforming material and product.
The evaluation of material and product non-conformance includes a determination of
the need for an investigation and notification of the persons or organisations
responsible for the non-conformance.
All evaluation and investigations are documented.
All GMP operational staff are trained to recognise material and product non-
conformance and take appropriate action, including identifying product as non-
conforming, documenting and evaluating the non-conformance, segregating and
disposal of non-conforming product.
Any non-conforming incoming material shall be immediately identified and
segregated. The discrepancy shall be clearly documented and the cause investigated.
In-process products and finished products not meeting specifications shall be clearly
labelled and held in a separate quarantine area until the discrepancy has been
investigated and resolved. The results are documented in the Batch Records and other
relevant forms or reports.
Disposition of the non-conforming material and product is documented, and includes
the justification for the use or rework of any non-conforming product after cause of
non-conformance is determined and the authorisation for use is approved.
The decision to use, rework or reject a non-conforming material and product is made
by the QA Manager.
Standard operating procedure for rework, retesting and re-evaluation of the non-
conforming product to ensure that the product meets its current approved
specifications has been established.
All rework and re-evaluation activities, including the determination of any adverse
effect from the product rework, must be documented in Batch Records.
Disposal of non-conforming product is the responsibility of the QA Manager and its
disposal is documented.
15. Corrective and Preventive Action Systems
Corrective and Preventive Action (CAPA) programmes to:
detect systemic problems and implement corrective actions in order to prevent
release of the non-conforming product to customer
implement preventive actions to continuously improve the Companys processes
and products
Some actions resulting from a customer complaint may be handled by CAPA.
The need for corrective / preventive action is identified from the following sources:
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product non-conformances
process non-conformances (manufacturing deviations)
deficiencies arising from internal or external (customer or regulatory) audit or
review processes
accidents, error or incidents within the plan
If the event is an isolated incident (not systemic), the cause is well defined and not likely
to occur again, then the issue may be dealt with according to the individual quality system
element and documented on the form specific to the issue.
If the event however is systemic (has other related incidents or is likely to re-occur in the
future if corrective or preventive action is not put in place) then it should be resolved and
documented.
16. Handling and Storage of Materials and Products
16.1 Handling
After receipt by appropriately trained personnel, orders are reviewed immediately
and reconciled against delivered Lots. All materials and finished products are
handled according to the companys handling and safety procedures.
16.2 Storage
Designated areas and conditions are provided to minimise deterioration and ensure
easy selection of correct stock, stock rotation as well as segregation of non-
conforming, rejected and returned materials.
All storage areas are temperature controlled and monitored
Incoming material movements are consumed and transferred on a First In First Out
(FIFO) basis.
The stock is monitored periodically for shelf life expiry, and action shall be taken
to remove and destroy stock that has short shelf life or has passed expiry or has
deteriorated.
16.3 Packaging
Products are delivered to customers using methods that minimise the effect of
transport conditions on product viability.
Products are packaged in approved packaging material referenced in the Product
Specifications with due regard to product stability, approved storage conditions,
cleanliness, environment and in such a manner as to prevent damage and
deterioration.
16.4 Preservation
Appropriate steps shall be taken to ensure that the conditions of storage and
transport are within the limits set by the customer, regulatory or other
specifications or are according to suppliers recommendations.
17. Control of Quality Records
The company maintains quality records required by the GMP standards to demonstrate
that the requisite manufacturing and testing control has been achieved.
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Quality Records include, but are not limited to:
Records which demonstrate that products supplied by the company meet technical,
regulatory and contractual requirements. This may include production Batch
Records as well as records from suppliers and subcontractors that relate to current
Good Manufacturing Practices.
Laboratory Test Records, and Specifications Records including raw data and any
electronic records if applicable
Logbooks
Records pertaining to product development.
Equipment calibration records
Validation and Commissioning records.
Equipment history files.
Records which demonstrate that all Quality Assurance activities have been
effectively implemented.
The Quality records are archived in secure storage, preserved during storage and are
readily retrievable in readable form for the entire retention period.
Records are documented and stored in designated locations that provide proper
accessibility.
The retention period of quality records is documented. At the end of the retention period,
they are destroyed within a designated time period or relocated to other storage areas.
The quality records shall be reviewed and analysed periodically to identify trends and to
implement continuous improvement of the systems.
All electronic records are backed up regularly. Access to archived GMP records is strictly
controlled.
These records are maintained and documented by the responsible department personnel
and the QA Manager,
Staff undergo training to ensure they complete both Batch Records and QC Test Records
in compliance with GMP requirements during operation.
A register of staff signatures and initials is maintained.
18. Internal Quality Audits
This is done to verify whether quality activities comply with the Quality Plan, to
determine the effectiveness of the Quality System and verify compliance with GMPs.
Every element of the quality system is audited at least once per year. The actual frequency
of such audits is determined according to the results of previous audits and the importance
of the activity.
Procedures for the stages of internal audit are:
Planning and Scheduling
Preparing for the Audit
Conducting the Audit
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Audit Reports and Corrective Action Requests (CARs)
Follow Up
Audits are carried out by approved auditors who are independent of the department being
audited. An audit schedule is maintained and controlled by Quality Assurance, and
communicated to the relevant function heads.
The audit schedule may vary according to non-conformances found and changing
circumstances.
The audit findings, corrective actions, timings and any requirements for follow up audits,
are agreed between the auditor and the auditee and reported.
The Management review meeting assesses internal audit and follow up report summaries
in order to help evaluate the effectiveness of the system.
Records will be kept in accordance with established policies and procedures.
19. Training Programmes
Training of Company staff is categorised into the following areas:
Induction and basic hygiene training for all new employees and contractors who
are required to enter the manufacturing area
GMP principles training on a regular basis
Skills or Competency training - SOPs, Test Methods and Master Batch Records
Department Manager shall prepare a training plan to be used for organising relevant
training sessions for the employee.
Training is carried out by appropriate internal and/or external personnel. This includes
training on specific tasks relating to the job performed as well as quality awareness.
The GMP training will include, but is not limited to, where applicable:
Regulatory standards and GMP requirements
Principles of cleaning and sanitation
Basic microbiology
Good Laboratory Practices
Good aseptic practices
Company documentation (SOPs)
Training records are held for each employee.These records link training to SOPs and other
relevant documents.
20. Statistical Techniques
Statistical techniques and methods are used to measure the inherent variability in these
processes in order to estimate the confidence levels associated with data and provide
information for effective decision- making.
Where appropriate, the company shall establish and maintain procedures for identifying
valid statistical techniques required for controlling and verifying the acceptability of
process capability and product characteristics.
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Statistical techniques are applied in the area of process control and quality control
activities to ensure that process capability and product characteristics are acceptable.
Appropriate statistical techniques will be applied to data generated from process
monitoring and testing.
These shall be used to analyse trends and variability and provide a basis for modifying
processes, if these are necessary.
Training in the use and application of statistical techniques are recognised as important.
21. Computer Systems Management
The control of computer systems which impact GMP activities is important to ensuring
control of processes, assessment of data, accuracy of manufacturing and control records
and compliance with industry regulations.
The following general requirements and policies apply to GMP related computer systems
Persons with appropriate expertise should be responsible for the design,
introduction and regular review of a GMP related computer system.
Where a computer is used in connection with any procedure or process associated
with the production of clinical trial material, the computer system employed should
meet applicable GMP requirements for those manual functions, which it replaces.
When a computer system is in process of replacing a manual operation the
computer system should show that it operates correctly and meet the specified
requirements.
Any change to an existing GMP computer system should be processed in
accordance with a defined change control procedure which should document the
details of each change made, its purpose and its date of effect and should provide
for a check to confirm that the change has been applied correctly.
Security of Computer Systems
A hierarchy of permitted access to enter, amend, read, or print out data shall be
established according to user needs. Suitable methods of preventing unauthorised
entry shall be available, such as pass cards or personal user-identity codes.
The recovery procedure to be followed in the event of a system breakdown shall be
defined in writing
22. Facility Control
The access to manufacturing facility is restricted. All staff must enter via designated
locked entry doors secured by key codes. On termination of employment, staff must
surrender all access key cards and access passwords must be deleted.
All contractors and visitors must sign an entry register, report to a designated employee
when entering the facility and be supervised at all times while in the facility.
No contractor or visitor may remove any sample, equipment, product or remove or copy
any document without the approval of the management.
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Facility Security: Monitoring and Alarms
The facility shall be access-controlled to prevent illegal entry and is also fire-
alarmed. In the event of power failure, the local and main alarm panels shall be
activated.
There is written procedures for facility evacuation and response to power failure.
Restrictions on Entry to Cleanroom and Manufacturing Areas
Within the manufacturing area, certain rooms are designated cleanroom areas.
Gowning standards are to be applied in these areas and no staff may enter these
areas unless they are properly gowned according the standard procedures.
All visitors to restricted areas must be accompanied at all times by a staff member.
23. Management of Equipment and Critical Process Utilities
Manufacturing and QC equipment and process utilities are uniquely identified during
installation.
The company generally follows the V Model principles for qualification of major
critical items of equipment or critical process utilities. For minor items this model may be
varied. The V model requires development of user, functional and design specifications,
which are used for design qualification.
Qualification of equipment, Installation Qualification (IQ), Operational Qualification
(OQ) and Performance Qualification (PQ) Qualification, shall be documented in pre-
approved protocols and reports.
Routine Monitoring, Maintenance, Calibration and Control of Equipment
All critical equipment and process utilities shall be monitored and controlled
during use according to the approved written procedures and schedules for
preventive maintenance.
Critical equipment and utilities, shall be tagged and removed from use when under
repair maintenance and shall not be used until cleared by the authorised person.
There shall be written procedures for start up, operation, shutdown, cleaning,
calibration and maintenance of all critical equipment and utilities.
Equipment and utilities history logs shall be maintained for all critical items.
All critical measuring devices/instruments shall be calibrated at defined intervals to
a written schedule, if necessary using qualified contract calibration laboratories.
Regular checks on the ongoing accuracy and performance of measuring devices
shall be conducted.
Water and Clean Steam System Control and Monitoring
The purified water system and associated clean steam system shall be regularly
monitored according to a written sampling and testing programme under the
control of the laboratory.
There shall be written procedures for sampling, testing and reporting results.
Action and alert limits are established and documented.
HVAC Systems Maintenance and Monitoring
The HVAC systems servicing all GMP cleanrooms shall be regularly maintained to
a written schedule. Records of maintenance shall be retained.
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Routine monitoring shall include daily recording and periodic trending of
cleanroom pressure differentials, at least quarterly cleaning of pre-filters, quarterly
inspection of Air Handling Units, at least annual certification of HEPA filters and
routine environmental monitoring programmes.
24. Validation Programmes
The company is committed to validating critical computer systems, equipment and
qualifying critical process utilities, validating cleaning procedures and processes, and
laboratory methods in accordance with GMP requirements.
The company has developed and published a Validation Master Plan (VMP) for the
construction and commissioning of the facility, equipment and utilities.
This document provides schedules, standards, acceptance criteria and responsibilities for
development and execution of protocols.
The validation of specific processes, cleaning and test methods shall be conducted
according to approved protocols.
Cleaning Validation Programmes
The validation of cleaning procedures for common equipment is considered
critical to prevent crosscontamination of biopharmaceutical products.
Wherever common equipment is used in manufacture, cleaning validation studies
shall be conducted.
All validations shall be conducted using approved protocols and cleaning
methods.
All new products shall be assessed for the suitability of the standard cleaning
procedures and whether additional validation studies are required.
All cleaning validation reports shall be prepared and submitted to Quality
Assurance for approval.
Laboratory Test Method Validation
Laboratory personnel shall be trained to follow standard procedures and specific
test methods.
All non-compendial laboratory methods shall be validated with the equipment and
reagents specified in the test methods.
All critical laboratory equipment involved in the measurement and testing of
starting materials, intermediates and finished product shall be qualified and
calibrated.
Any contract testing laboratory shall be qualified, preferably approved by a
regulatory agency.
Pharmacopoeial Test Methods
The company uses compendial (BP/EP/USP/etc.) methods where applicable. Test
methods that are published in the British Pharmacopoeia (BP), and/or the United
States Pharmacopoeia (USP) do not require full validation but shall be
demonstrated to be accurate, precise and selective before use.
The company recognises it is therefore good laboratory practice to conduct some
method transfer ruggedness studies even on compendial methods before use.
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Non Pharmacopoeial Test Methods
Non pharmacopoeial test methods shall be fully validated. The level of validation
and responsibility for validation shall be discussed with customers as part of
technology transfer.
25. Occupational Safety and Health Programmes
As an integral part of employee induction, all Manufacturing operational staff will be
instructed in occupational health and safety policies and procedure.
Before operating equipment or handling biologically hazardous materials, staff will be
instructed on safety procedures and correct gowning.
All biological hazardous materials shall be decontaminated before disposal.
The companys policy and GMPs require that staff undergo the following OS&H
procedures:
Pre-employment medical checks.
Periodic medical checks for staff who are required to handle or manipulate
biological hazardous materials.
Temporary exclusion of staff from manufacturing areas and cleanrooms if they
carry a communicable condition, including respiratory infection or open skin
wounds.