Title: Control of Substance Hazardous to Health

Type: SOP No.: HSE/…… Version No.: 01 Master Stamp

1. Definition
Term Definitions & Abbreviations
Refers to workplace procedures adopted to reduce injury, reduce
Hazard control adverse health effects, and control damage to people or
equipment.
Any substance labelled as very toxic, toxic, harmful, corrosive,
A substance sensitizing or irritant under the Chemicals Hazard Information
hazardous to health and Packaging for Supply RegulationsSDS or Any substances
which could create a similar hazard to any of those substances
LEV Local Exhaust ventilation

PPE Personal Protective Equipment

COSHH Control of Substances Hazardous to Health

PEL Permissible Exposure Limit

2. Forms
Attach. /Forms/SOPs Title
HSE/…/01HSE/23/01 ‫ نموذج صرف األدوية‬COSHH Risk assessment form
HSE/…/02 Hazardous Substance Inventory
HSE/23/03 ‫نموذج تسجيل الزيارات المرضية‬
HSE/23/04 ‫النموذج الشهرى لحصر وتسجيل االدوية‬
HSE/23/05 ‫نموذج إدراج وتسجيل األدوية‬
HSE/23/A01 P‫كيف تطهر يديك‬
HSE/23/A02 ‫استقبال العاملين بالعيادة‬
HSE/23/A03 ‫استخدام جهاز النيبوليزر‬
HSE/03/01 ‫نموذج التخلص من المخلفات‬
3. Objective
3.1.To specify the requirements and procedures for COSHH assessments in all areas on the
pharco corporations’ site where exposure to substances hazardous to health may occur
including during the technology transfer for a New Chemical Entity or during product
transfer or the design, installation and commissioning of new plant, equipment and
facilities.
4. SCOPE
4.1.The procedure applies to the Pharco corporate
4.2.The procedure sets out general guidelines and responsibilities for assessment, particular
guidance is given for:
4.2.1.The development and introduction of new products, plant, equipment and facilities
4.2.2.The use of substances hazardous to health in any technical, manufacturing or service

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 Title: Control of Substance Hazardous to Health

Type: SOP No.: HSE/…… Version No.: 01 Master Stamp

function.
4.2.3.Demolition/decontamination work.
4.3.A substance hazardous to health is defined as
4.3.1.Any substance labelled as very toxic, toxic, harmful, corrosive, sensitizing or irritant
under the Chemicals Hazard Information and Packaging for Supply Regulations.
4.3.2.Any substance which has been assigned a permissible Exposure Limit (PEL) by the
OSHA.
4.3.3.Substances that have delayed or chronic effects, e.g. substances that are
carcinogenic, mutagenic or toxic for reproduction.
4.3.4.Biological agents (e.g., micro-organisms) which may create a hazard to health.
4.3.5.Dust of any kind when present in ‘substantial airborne concentrations’ e.g. excipients
and other low toxicity dusts.
4.3.6.Carcinogens

4.3.6.1.Special provisions exist for carcinogens and mutagens. There is a greater duty to
prevent exposure to carcinogens and metagenes and COSHH defines
particular steps which should be taken when assessing whether adequate control
has been achieved (see Appendix 1). When handling carcinogens or metagenes
further assistance should be sought from Occupational safety.
4.3.7.Biological Agents

4.3.7.1 When assessing exposure to a biological agent the “approved classification” (as
given in the “Categorization of Biological Agents according to Hazard Categories
and Containment”) shall be taken into account
4.3.7.2 The above document also provides guidance on the controls to be applied when
working with biological agents falling within the different categories.
4.3.7.3 When handling biological agent’s further assistance should be sought from
Occupational Hygiene.
.‫جميع اإلدارات بالشركة‬ .4.4
5. ‫المسؤولية‬:Responsibility‫(قطاع السالمة والصحة ال(عيادة الشركة‬..
5.1.Production managers.
5.2.QC & R&D managers
5.3.Engineering managers
5.4.Procurement manager
5.5.Health care responsible
5.6.HSE Representatives
6. ‫المسائلة‬Accountability:

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 ‫‪Title:‬‬ ‫‪Control of Substance Hazardous to Health‬‬

‫‪Type: SOP‬‬ ‫……‪No.: HSE/‬‬ ‫‪Version No.: 01‬‬ ‫‪Master Stamp‬‬

‫‪6.1.HSE manager‬‬

‫‪.‬مدير إدارة السالمة والصحة المهنية لضمان التنفيذ الفعال‬

‫‪:Procedures:‬خطوات العمل ‪7.‬‬

‫‪.‬يتم استقبال السادة العاملين بالشركة لتقديم خدمات الرعاية الصحية على النحو التالى تبعا لنوع الحالة المرضية ‪8.‬‬
‫الحالة االولى ‪9.‬‬
‫وهى حالة بسيطة ال تحتاج الى تدخل طبي متخصص يمكن اجرائها بواسطة مسؤول العيادة (الممرض) داخل العيادة وهى تتمثل ‪10.‬‬
‫في‬
‫اإلسعافات األولية من قياس نسبه السكر وقياس ضغط الدم ودرجه الحرارة والتنفس الصناعي بجهاز التنفس باألكسجين واجراء ‪11.‬‬
‫‪.‬الغيارات الطبية الالزمة لإلسعاف األولى‬
‫الحالة الثانية‪12.‬‬
‫هى حالة مرضية تحتاج الى فحص وتشخيص وعالج باستخدام األدوية بواسطة طبيب مختص وبتم التعامل مع هذة الحاالت ‪13.‬‬
‫بواسطة طبيب المنشأة الذائر حال تواجدة اما فى حاالت الواردى او عدم تواجد الطبيب او عدم كفاية االوسائل الطبية بالعيادة‬
‫‪.‬يتم التحويل الى اقرب مستشفى متعاقد معها من قبل الشركة لتلقى الخمات الطبية العاجلة من قبل مختصين‬
‫الحالة الثالثة‪14.‬‬
‫تتمثل فى حاالت الحوادث وأصابات العمل وهى حالة طارئة تحتاج الى تدخل طبي عاجل ويتم تصنيف هذة الحوادث ‪15.‬‬
‫واالصابات من قبل مسؤول العيادة الى اصابة بسيطة ال تحتاج الى تدخل طبي متخصص يمكن التعامل معها بواسطة مسؤول‬
‫العيادة (الممرض) داخل العيادة مثل الجروح الوخزية والقطعية السطحية البسيطة ‪ ,‬الحروق من الدرجة األولى ‪ ,‬االختناقات‬
‫وضيق التنفس البسيطة نتيجة الحساسية الموسمية او التعرض للكيماويات التى تحتاج الى جلسة تنفس باألكسجين ‪ ,‬الكدمات‬
‫‪.‬البسيطة ‪ ,‬حاالت األغماء القصيرة‬
‫اما عن الحوادث واصابات العمل اللغير بسيطة والتى تحتاج الى فحص وتشخيص وعالج باستخدام األدوية بواسطة طبيب ‪16.‬‬
‫مختص بتم التعامل مع هذة الحاالت بواسطة طبيب المنشأة الذائر حال تواجدة وقدرتة على التعامل والسيطرة على الموقف‬
‫‪.‬بأستخدام الوسائل المتاحة بالعيادة وتحت مسؤليتة الشخصية‬
‫اما فى حاالت الواردى او عدم تواجد الطبيب او الطبيب او عدم كفاية االوسائل الطبية بالعيادة يتم التحويل الى اقرب مستشفى ‪17.‬‬
‫‪ .‬متعاقد معها من قبل الشركة لتلقى الخمات الطبية العاجلة من قبل مختصين‬
‫يتم فحص المصاب بالكامل واالهتمام باإلصابة وذلك ألنه غالبا ما يكتفى المسعف باإلصابة األولى خاصه إذا كانت هذه اإلصابة ‪18.‬‬
‫كبيره ويمهل باقي اإلصابات الصغيرة والتي قد تكون لها خطورتها‬
‫)‪ (HSE/23/03‬يتم تقديم الرعاية الطبية المناسبة والفورية للمصاب حسب اإلصابة أو المرض وتسجيل ذلك في النموذج رقم‪19.‬‬
‫‪ (HSE /23/01).‬يتم صرف وتلقى األدوية داخل العيادة بواسطة الطبيب الزائر فقط ويتم تسجيل ذلك بالنموذج رقم‪20.‬‬
‫‪.‬يتم تقديم خدمه الكشف الطبي من خالل الزيارة الدورية للطبيب الزائر للشركة‪21.‬‬
‫‪.‬في حالة الضرورة يتم نقل المصاب إلى المستشفى أو أحد المراكز الصحية إذا ما استدعت الحالة‪22.‬‬
‫‪.‬يتم استخدام الحقن الطبية والسرينجات داخل العيادة بواسطة الطبيب الزائر للشركة فقط‪23.‬‬
‫‪HSE/23/04) ).‬يقوم مسئول السالمة والصحة المهنية بتسجيل وحصر كافة األدوية الموجودة بالعيادة شهريا في نموذج ‪24.‬‬
‫يتم وضع المخلفات الطبية الصلبة داخل كيس احمر مخصص للمخلفات الطبية‪.‬كما يتم استخدام صندوق اصفر خاص بالتخلص ‪25.‬‬
‫‪.‬من الحقن والسرينجات والمحتويات الطبية الحادة المستخدمة بواسطة الطبيب الزائر‬

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26. ‫ يتم التخلص من المخلفات الخاصة بالعيادة باستخدام نموذج التخلص من المخلفات‬HSE/03/01
27.) ‫ تاريخ الصالحية‬-‫االستخدامات‬-‫يتم ادراج اسماء االدوية الموجودة بالعيادة مع تتعيين (الشكل الصيدلى للدواء‬
28.)‫ محاليل تطهير وتعقيم‬-‫ شاش طبي – بيتادين‬-‫ بالستر طبي‬-‫ محتويات االسعافات األولية (قطن‬P‫كما يتم تعيين‬
29.‫(( وتسجيل ذلك في النموذج رقم‬HSE/23/05 ‫ويتم التخلص من االدوية الباقية علي صالحيتها شهرين‬.
30.‫يتم تطهير وتعقيم األدوات الخاصه بالعيادة شهريا بمعرفة معمل الميكروبيولوجى بالشركة وتسليمها لمسؤول العيادة‬.
30.1. Information Instruction and Training
30.1.1. The guidance on working with substances hazardous to health. Will be located
in Appendix 1.
30.2. Purchase of substances
30.2.1. All substances must be ordered through the corporation Procurement System. A
material safety data sheet must be delivered with the substance through procurement
department.
30.2.2. important consideration should be given to the availability of a less hazardous
substance, such as safe needles or other sharp devices.
30.3. Product Identification, labelling and storage
30.3.1. All products containing a hazard symbol are potentially hazardous to health.
Therefore, it is necessary to look for the hazard symbols on the packaging and also
note the essential storage requirements as referred to in the material safety data sheet.

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 Title: Control of Substance Hazardous to Health

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30.3.2. It cannot be over emphasized the importance of thoroughly reading the material
safety data sheet as this document provides ALL relevant product information.
30.3.3. It is important that the product remain in its original packaging and is stored
safety in an appropriately labelled hazardous substance cabinet.
30.4. Completion of Inventory of Substances and COSHH Related Activities
30.4.1. All products with a hazard symbol must be entered on to the Inventory for the
Department.
30.4.2. You must also consider any work activities where you may be at risk of harm
30.5. HSE representative
30.5.1. A HSE representative will be the competent person who has sufficient training,
experience, or knowledge and other qualities that allow them to identify the hazards
associated with a particular product or task.
30.6. Personal Protective Equipment (PPE)
30.6.1. PPE must be provided and correctly used where it is referred to as a requirement
in the material safety data sheet and/or COSHH Risk Assessment/SOP. This PPE must
be suitable and sufficient, and where necessary FIT testing must also be provided to
staff. Remember that PPE is always a last resort after all other controls have been put
in place.
30.7. Emergency arrangements
30.7.1. Emergency arrangement must be specific for each product or task and must be
prominently displayed for hazardous substances such as cytotoxic substances and for
use of formalin. It is important that all staff working in the location must be given
information, instruction and training on emergency spillage including drills, and
arrangements for first aid. It is important that consideration must be given to the volume
of a spillage and the adequacy of the spillage kit to deal with any such emergency.
30.8. COSHH risk assessment
30.8.1. The HSE responsible or other competent person, will undertake the COSHH Risk
Assessment.

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30.8.2. During the risk assessment process, a hierarchy of control must be put in place.
The hierarchy of hazard control is a system used to minimize or eliminate exposure to
the. hazards.
30.8.3. suitable and sufficient COSHH assessment MUST be completed before
undertaking any work that may expose any employee, other persons on the premises
(e.g. visitors or contractors).
30.8.4. Risk assessments must contain sufficient detail on the preventative and
protective measures to be taken to control the risks, including a suitable and sufficient
risk assessment around the use of non-safe sharps in areas where it is not reasonably
practicable to do so
30.8.5. toxicological endpoints are aligned with GHS classification and labeling system
30.8.6. Important goal is to relate potency of each toxicological hazard‐banding
endpoint to GHS hazard statements and categories, when possible, Will be located in
Appendix 2.
30.8.7. The assessment should involve a consideration of:
7.8.5.1.Which substances or types of substances employees are liable to be exposed.
7.8.5.2.What effects those substances can have on the body.
7.8.5.3.Where the substances are likely to be present, in what quantity and in what
form.
7.8.5.4. The ways in which and the extent to which any groups of employees

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 Title: Control of Substance Hazardous to Health

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or other persons could potentially be exposed.
7.8.5.5.An estimate of exposure, taking into account engineering measures and
systems of work currently used for controlling potential exposure.

7.8.6. Hazard information about the substances on which the assessment is based
should be presented in Section 1 (Substance’s information) of the COSHH
Assessment form HSE/42/01.
7.8.6.1.Examples and hazards found in a pharmaceutical industry may include:
7.8.6.1.1. Disinfectants.
7.8.6.1.2. Certain pharmaceutical agent where there is a risk to those
administrating.
7.8.6.1.3. Gases.
7.8.6.1.4. Biological agents.
7.8.6.1.5. Dust.
7.8.6.1.6. Chemicals
7.8.6.2.Example formalin.
7.8.6.2.1. Formaldehyde is a gas at room temperature. It is colorless, and has a
characteristic pungent irritating odor. Solutions of formaldehyde in
water, commonly called formalin, are used as disinfectants and for
preservation of biological specimens.
7.8.6.2.2. Exposure to formaldehyde is a significant consideration for human
health, and is known to be a human carcinogen.
7.8.6.3.Cytotoxic drugs
7.8.6.3.1. All hazardous drugs are potentially hazardous and must be handled
with respect. Many are known to be carcinogenic (cause cancer),
teratogenic (cause birth defects) and may also cause local irritation on
skin or eye contact.
7.8.6.3.2. All staff must be aware as to which drugs are cytotoxic and where
these drugs are stored, transported and handled, including the
disposal of cytotoxic waste
7.8.7. All substances need not be listed, only KEY substances. Selection of KEY
substances should in the first instance be based on the most hazardous substance.
7.8.8. Drawings, specifications and baseline measurements of local exhaust ventilation
systems or other engineering controls should be cross referenced in the assessment.
7.8.8.1.control systems will be identified by the relevant Departmental Manager
(Engineering) and then agreed with the Departmental Manager
(Production). Testing of LEV systems MUST include:
7.8.8.1.1. A weekly visual inspection and a simple monthly (minimum).
7.8.8.1.2. All records of maintenance, examination and testing of LEV systems.
7.8.8.1.3. MUST be kept for at least 5 years.
7.8.9. A COSHH assessment MUST be reviewed if there is any reason to suspect that it
is no longer valid or there has been a significant change in the assessed work.
The assessment may no longer be valid if, for example
7.8.9.1.A new substance is introduced. New substances MUST NOT be

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 Title: Control of Substance Hazardous to Health

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introduced into an existing process without considering the implications
of the change.
7.8.9.2.Occupational Environmental monitoring data indicates higher exposure
than law limit
7.8.9.3.The results of health surveillance or reports of occupationally induced
disease indicate a higher incidence of adverse reactions than anticipated.
7.8.9.4.Health and Safety surveys or audits indicate that prevention or control of
exposure could be significantly improved.
7.8.9.5.New information on potential health hazards is received including changes
in the Occupational Exposure Level.
7.8.9.6.Other significant changes in the work which may warrant review include:
7.8.9.6.1.changes in the substance(s) used or their source.
7.8.9.6.2.plant modification including engineering controls.
7.8.9.6.3.changes in the process or working methods.
7.8.9.6.4. changes in the volume or rate of production beyond that covered in
the original assessment.
7.8.9.6.5.changes in shift patterns and overtime or extended working.
7.9. Introduction of New Pharmaceutical Products
7.9.1. When pharco corporate t e a m i s e s t a b l i s h e d f o r t h e t r a n s f e r o f technology to
production the Technology Transfer Leader (TTL) will usually lead the site technology
transfer and has responsibility for preliminary risk assessments during product
development and will assume stewardship of health and s a f e t y information. The
C u s t o m e r R e p r e s e n t a t i v e w i l l d e v e l o p t h e COSHH assessment for the
manufacturing process or update the current assessment by means of the supplement
form, including maintenance, cleaning and emergency procedures. This information
MUST be used.
7.9.1.1. as a basis of any subsequent assessment of the final process.
7.9.1.2. by Managers whose staff will come into contact with the product during
development to prepare COSHH Assessments for their own work.
7.10. New Equipment, Plant and Facilities: Preliminary Assessments
7.10.1. During the design and construction of any new equipment, plant or facilities (for new
or existing products) the customer (production) representative on the project team is
responsible for defining production requirements for the control of hazardous
substances based on the preliminary COSHH Assessment of the process.
7.11. Demolition / Decontamination
7.11.1. Exceptional exposure to hazardous substances may occur during
building/equipment decontamination or demolition.
7.11.2. Where specialist contractors are used for demolition/decontamination, the
contractor MUST produce method statements which detail the risks and the control of
hazardous substances for their operations.
7.11.3. Where pharco staff are carrying out the work, the Project manager/engineer is
responsible for ensuring that a method statement is completed where necessary.
8. References:
8.1. Environmental Law No. 4 of 1994, as amended by Law No. 9 of 2009.

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8.2. Egyptian Labor Law for 2003

8.3. The control of substance hazardous to health regulation 2002

9. Appendices:
9.1. Appendix 1

Eight Steps of COSSHH Assessment

Assess the risks to health from

hazardous substances used in or
Step 1 Assess the risks
created by your workplace
activities

You must not carry out work which

Decide what precautions
could expose your employees to
Step 2
are needed hazardous substances without first
considering the risks

Prevent or adequately
Step 3 You must prevent your
control exposure employees being exposed to

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hazardous substances. Where

preventing exposure is not
reasonably practicable, then you
must adequately control it. The
advice in the COSHH Policy, and
other guidance will help you to
make correct assessments and
to put the appropriate controls in
place

Ensure that control Ensure that control measures are

measures are used and used and maintained properly,
Step 4
maintained and that safety procedures are
followed

Monitor the exposure of

Step 5 Monitor the exposure employees to hazardous
substances, if necessary

Carry out appropriate health

Carry out appropriate surveillance where your
Step 6 assessment has shown this is
health surveillance
necessary, or where COSHH
sets specific requirements

Prepare plans and Prepare plans and procedures to

procedures to deal with deal with accidents and
Step 7 accidents, incidents and emergencies involving
emergencies hazardous substances, where
necessary

Ensure employees are You should provide your

properly informed, trained employees with suitable and
Step 8
and supervised sufficient information, instruction
and training.

9.2. AppendiX2

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10. SOP History page:

Version No. Effective Date Change Description
01 18/11/2021  First issuance of document

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