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A Confined Space Safety Policy can be divided into 9 sections.

This article briefly describes the nine parts of a comprehensive yet efficient confined space safety

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

program.

1 - Purpose - The confined space safety policy states the requirements for the identification and safe entry into both permit required and

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

non-permit required confined spaces. The policy applies to areas of the workplace not designed for continuous occupancy and containing recognized serious safety or

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ealth hazards.

2 - Reference - OSHA 29 CFR 1910.146

3 - Scope - Applicable to all of the business's employees, visitors and contr

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

actors.

4 - Administration - Variable, but generally administration of the confined space policy is by safety coordinators, supervisors, engineers

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

nd other trained managerial staff.

5 - Definitions - Can be standard, see: OSHA, Occupational Safety and Health Act

6 - Descriptions
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ng> -

Confined Space is an area/space where an employee: - has limited openings for entry and egress; - can bodily enter and which is large enough to pe
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
rform assigned work; - could be engulfed by bulk materials; - is not intended to continuously occupy.

Non-Permit Required Confined Space is a confined space neither
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
containing nor having the potential to contain any hazard.

Permit Required Confined Space is a confined space with: - a hazardous atmosphere or potential for it; -
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
aterial that could engulf an entrant; - converging/tapering walls/floors that could entrap or asphyxiate; - a recognized hazard.

Procedures Followed For All Permit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
equired Confined Space Entry

- Permit

- - Issuance - By the supervisor, mandatory for the employee, one shift in duration.

- - Cancellation - At shift
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
end or on job completion.

- - Retention - Must be reviewed and kept.

- Alternate Entry/Space Reclassification - Specific ref: OSHA 29 CFR 1910.146 (c
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
(5)/(c)(7)

- Pre-Entry Briefing - By permit issuing entry supervisor.

- Contractor Notification - Outside contractor adheres to procedures - compliance must be ass
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
red.

- Lighting Requirements - Natural, auxiliary, emergency.

- Special Tools and Equipment - Intrinsically safe in flammable or combustible atmosphere.

- Prepara
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
tion and Hazard Control - Preventing engulfment, burns. Lockout/tagout procedures.

- Assuring adequate ventilation.

- - Pre-Entry Atmospheric Testing
t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
Includes employee training with testing equipment.

- - Monitor Calibration and Testing - Field and Manufacturer Testing.

- Attendant Duties - Mandato
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
y for permit required confined space entry, no other duties.

- Entry Supervisor Duties - Trained and authorized entry supervisor.

- Safety Equipment - PPE, non-ent
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ry rescue, rescue, general.

- Equipment Inspection - Per manufacturer's recommendation.

- Handling Problems.

- Rescue and Emergency Services - Documented, availab
.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
e, trained, equipped.

- Summoning Rescue Services Procedure

7 - Responsibilities - Employees and Entry Supervisor - Safety
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
oordinators - Supervisors - Contractors

8 - Training - Initial - Refresher - Annual

9 - Revision - Annually by Safety Coordinator

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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