Safety in the Pharma Industry
Tuesday, April 24, 2001 11:16 IST
The Bhopal gas tragedy that shook the conscience of the entire industrial world in December 1984 had occurred due to leakage of poisonous gas, though the safety profile was maintained in their plant too. The aftermath of this incident resulted in the Government coming out with certain guidelines for all manufacturers, particularly Chemical Industry, to prevent such types of accidents. The Factories Act also stipulates some essential safety standards including onsite Emergency Master Plan (Amendment in 1987), which must be complied by industry besides Pollution Control Boards provisions.
It is certain that there is little chance of recurrence of such an incident of such severity through the formulations industry. Even then the manufacturer must apply all safety profile to ensure total accident-free operation throughout the year in their factory.
Nowadays it is clear that an accident damages the factory and their reputation besides having to dole out huge compensation and even face the prospect of closure. In the pharmaceuticals industry, various chemicals are being handled through several equipment, machinery and processes using electricity and mechanical devices. Various microorganisms are also being handled both in the laboratory and in production process. So it is required to study the whole setup, machinery, process, raw materials, chemicals, microorganisms, etc. thoroughly. It is also required to identify all possible hazards and then take preventive and corrective measures to prevent the accident. In view of these, it is necessary to consider all these aspects for safety purpose during planning and implementation of project. This helps in prevention of accidents during running of plant.
For evaluation of safety aspects, the following steps
are narrated: -
1) Source of hazard.
2) Type of hazard
3) Control procedure
4) Contingency plan
Possible sources of hazard:
Handling and processing of inflammable and combustible raw materials
Handling of compressed gases.
Handling and processing of toxic substance
Handling of corrosive substances
Handling of oxidising substances
Operating electrical & mechanical - operated machineries for manufacture and testing of products
Handling of dust-producing equipment and also dust
Handling of boiler
Handling of various microorganisms in manufacture and also in testing of drugs
And several other operations in Pharmaceutical Industry for production and testing of drugs.
Types of hazards:
Injury and death
The framing of the control-procedure is an essential criterion in manufacturing houses so as to provide safe work environment in working place as well as to prevent accident.
In pharmaceutical industry the manufacturing control procedures are prescribed in elaborate way as per the provision of Schedule M of the Drugs & Cosmetics Acts & Rules. Besides this the provisions of GMP (Good Manufacturing practices) and GLP (Good Laboratory Practices) are also adopted in to which covers total aspects of the factory i.e. building, plant set-up, process, personnel, Quality assurance, manufacturing control procedures, documentation etc. which certainly provide safe work environment. However the lapses or deviation in procedures lead to accidents hence the concerned personnel should always be alert to avoid lapse / deviation of even slight nature.
Hence for ensuring total safe work environment and to prevent accident, the under mentioned control procedures may be adopted.
a) Standard Operating Procedure (SOP)
b) Safety Policy
d) Safety Audit
e) Risk Analysis
f) Preventive Maintenance
g) Involvement of Personnel
Standard Operating Procedure (SOP) :- In the pharma industry SOP is prepared in more elaborate manner for manufacture of each formulation. All the processes are carried out within the prescribed operational parameters. It is of utmost importance to adhere to the SOP and all parameters, which automatically provide safety. Hence for total safety it is required to include critical points and relevant corrective measures for all processes and also include the facilities provided in SOP with operating instructions. The SOP complete in all respects, ensures total safety in Pharmaceutical industry.
Safety Policy:- Besides processing, there are several sources (stated above) which may create accident. Hence it is imperative to define a safety policy and assigned the task to a safety officer. The safety policy is to be made as accident prevention and control programme to provide safety in factory and in office, too to each employee. This is drawn by considering all phases of company''s activities with the followings: -
acceptable level of operational risks
standard of industrial hygiene
delegation of responsibility to employees as staff function
Process of alternation, modification or change in procedure in case of deviation or apprehension of accident
Steps to be taken in case of accident
The Company''s safety policy should be hanged - up in notice board for information to all employees.
Monitoring:- It is essential to monitor each & every operation for getting success. Hence all the processes & safety aspects must be monitored. It is also required to closely monitor the effectiveness of all safety tools on regular basis. On getting deviation or lapses, the cause is detected and the remedial measures are recommended for immediate implementation.
Safety Audit:- Audit is an essential step to check the application of systems in true manner. Hence safety audit is to be done at regular interval so as to ensure the following-up of SOP with parameters, critical points, safety aspects and all steps for prevention of accidents. In this respect, it is better to draw a ''safety audit format'' which will be helpful during auditing by ''safety officer'' or their authorised representative.
Risk Analysis:- There are chances of occurring of several types of unwanted accidents in factory premises including office which may be fatal. (The sources of hazards have been already discussed above1.0) analysis in systemic manner by considering all aspects covering men, machine, processing, activities, building and all events including hazard due to human error or failure of any of the operation or tool. After evaluation of ''Risk Analysis'' the ''Safety measures'' are developed. Accordingly the safety aspects are incorporated in SOP and safety policy.
Preventive maintenance:- Several accidents are avoidable by taking precautions and timely maintenance of machineries, building, pipelines etc. So effective maintenance programme will certainly eliminate accident. Accordingly preventive maintenance must be planned to overtone any dangerous situation. These aspects should be incorporated in SOP, Safety Audit format, safety Monitoring format and safety policy.
Involvement of Personnel:- Most of the accidents are caused due to lapses on the part of person concerned. So it is imperative that the person concerned must be alert during work, which will present accident certainly.
Hence it is most essential to involve all personnel in safety programme. All employees must be informed of safety policy and the concerned employees should be made fully aware about concerned safety aspects involved with him. (Processing/Machines/Chemicals/Microrganisms handled by him). It is also required to motivate employees by arranging workshop/Seminar on safety aspects and also by presentation of awards for accident free performance. Time to time all employees should be appraised about new development on safety and also about accident prevention programme. They should be provided with preprinted instruction sheets and checklist for their operation and working area.
There is a need to prepare ''Contingency Plan'' for dealing with accidents in factory, which may occur and are likely to affect life and property, both within the industry and in the immediate neighborhood. So each industry has to formulate an on-site "Emergency Management Plan" detailing explicitly action to be taken and by whom in the event of accident occurring on site. It should contain in detail the problem, rapid control, action to prevent from further escalation, and all control procedures so as to prevent damage to life. property and environment.
In a nutshell it is concluded that safety / aspects must be considered by pharmaceutical manufacturer in the interest of employees, firm property and immediate neighborhood. The source of possible hazards, risk analysis, control-procedures, preventive measures & contingency plan are the main five essential steps for ensuring accident free as well as complete safe environment in factory. Documentation is also a supportive tool in safety programme. All the manufacturers should follow safety aspects in their factory.
About the author:The author is based in Kolkata and writes on industry issues.