Personnel Hygiene in Pharmaceuticals: Its importance and requirements for personnel involved in the manufacturing of quality medicines

 

Muddukrishna B S¹*, Vamshi Krishna T.², Lalit Kumar², M. Sreenivasa Reddy², Thunga Girish³, Girish Pai K²**

¹Department of Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal - 576104, Karnataka State, India

²Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal - 576104, Karnataka State, India

³Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal - 576104, Karnataka State, India

*First Author E-mail : krishna.mbs@manipal.edu

 

ABSTRACT:

Good personal hygiene is required in pharmaceutical industries to safeguard the product and avoid any type of contamination that effects quality of medicinal product. Individual persons are responsible for quality of a medicinal product and hence collectively can be termed as “personnel”. Even though controls are in place to manage equipment, incoming raw materials or packing materials, human beings are one of the main source of contamination. It is not enough to have a high tech state of the art pharmaceutical manufacturing facility and Quality control unit to release the raw materials, it is also very much essential to have well trained personnel to operate the equipment, to manufacture the quality product and handle the pharmaceutical product at every stage in manufacturing a dosage form. Therefore, all the personnel employed by the pharmaceutical sector should be well trained and educated on the importance of personnel hygiene. In this article, the authors have tried to outline importance of personnel hygiene and opined that there is a need to stress more on this subject especially at undergraduate levels of pharmacy curriculum. If this is included at undergraduate level, it will be easy to inculcate the best practices as per Good Manufacturing Practices (GMP) for the freshers entering the pharmaceutical manufacturing sector.

 

 

 

 

INTRODUCTION:

It is commonly said that cleanliness is next to godliness. This statement is more apt to the chosen topic “Personnel hygiene in pharmaceuticals” since the personnel involved in pharmaceutical industries handle the medicines which are to be administered to patients suffering from various infectious and life threatening diseases. Just imagine a medicinal product being contaminated and administered to a patient and the consequences thereafter or its serious implications. FDA as a regulatory authority gives prime importance to personnel hygiene and best practices followed in the manufacturing facility¹. This area is routinely audited by FDA inspectors for compliance and regularly check the training records to confirm the same. Therefore, this article will cover various important aspects of personnel hygiene and best practices to be implemented in the pharmaceutical industry. The authors have also compiled few examples from past industrial experience as well.

 

PERSONNEL HYGIENE:

Good personal hygiene is nothing but keeping oneself clean because many pathogenic or disease-causing bacteria come from operators / human beings working in the facility². Hygiene can be defined as system of sanitary principles to preserve health. Personal hygiene refers to cleanliness of a person’s body.

 

General requirements to be followed by personnel at all levels of working in the pharmaceutical facility ³

·       As a requirement of GMP, all personnel should undergo medical checkup which is a prerequisite for safe working condition.

·       Proper training on personnel hygiene to be imparted to all the personnel working in the facility.

·       Personnel not keeping well or having open wounds and skin infections are not allowed to enter the manufacturing facility.

·       Those employees who are on medication for serious illness shall not enter the facility and report the condition to department head or concerned.

·       Relevant personnel protective equipment (PPE) shall be used by the employees as per the requirement which will help protect both the product and personnel from untoward incidents.

 

Standard personnel hygiene procedure to be followed in a pharmaceutical facility is listed below ³

 

1.     It shall be the responsibility of all employees to maintain personnel hygiene within the factory premises.

2.     All personnel shall undergo medical examination upon recruitment.

3.     Every person entering the manufacturing areas shall wear protective garments appropriate to the operations carried out.

4.     It shall be the responsibility of the employee to take bath and shave regularly.

5.     All men employees shall be instructed to have regular haircuts. Nails should be kept short and clean.

6.     Eating, drinking, chewing or smoking, or the storage of food, drinking materials or personal medication in the production and storage areas shall be strictly prohibited.

7.     Any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected shall be forbidden.

8.     No person with infectious disease or having open lesions on the exposed surface of the body shall be engaged in any manufacturing.

9.     It shall be the responsibility of the employee to inform about any illness/weakness to the Department Head.

10.  Personnel suffering from contagious disease and any major disease shall be certified by medical doctors after treatment before resuming duty.

11.  Direct contact shall be avoided between operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the products.

12.  Personnel shall be instructed to use the hand washing facilities before entering production departments.

 

Additional precautions and best practices for consideration ^1,3,4

Health related:

v If any employee is suffering from infectious disease like conjunctivitis or severe cold, then that person should not report to work.

v The workmen should be encouraged to report infectious diseases to their respective department heads.

 

PERSONNEL CLEANLINESS:

v Employees should take bath every day.

v Hands should be cleaned regularly and certainly always with soap after visiting the toilet.

v Nails should be clipped regularly.

v Hair should be kept short and clean at all times.

v Employees should have clean shave and not to keep beards.

v Should wear clean clothes while entering the facility.

v Wearing jewels like rings, bracelets, chains and wrist watches should be avoided by the personnel working in production area during the work.

v Food, drink and other eatables must not be consumed in the manufacturing, packing, storage and laboratory areas.  This includes chewing of pan by personnel.

v Wear clean uniform or manufacturing gowns.

v Persons working in production area should not lean and keep his legs on the wall.

v Should not sit on the production equipment or intermediate product container or floor.

v Perfumes and nail polish should be avoided by the personnel

 

Related points for consideration ³

v Never use torn primary / secondary gowns, damaged shoe or head caps.

v Do not exit in company uniform.

v Do not spit.

v Smoking is strictly prohibited and is a statutory requirement.

 

Few important guidelines issued by World Health Organization for pharmaceutical industries ⁴

a)     Personnel conducting visual inspections should also undergo periodic eye examinations.

b)    Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.

c)     To ensure protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized.

d)    Personal medicines should not be allowed in manufacturing area, laboratory and storage areas or in any other areas where they might adversely influence product quality.

 

CONCLUSION:

These procedures / practices are applicable to all the personnel involved in the manufacturing activities that helps to maintain personnel hygiene and avoids any sort of contamination of medicinal product. This is applicable to staff at all levels right from housekeeping personnel to plant head. The overall accountability lies with the concerned department head for adhering to this procedure. There is a need to include a separate chapter or subject on personnel hygiene in the pharmacy curriculum which will help the students to understand the need and concepts of personnel hygiene as per FDA standards. Finally, to conclude, personnel hygiene should be an integral part of training program in the pharmaceutical industry especially for the new recruits apart from experienced employees. This is the reason ‘c’ in cGMP plays a major role, i.e., updated requirements are to be met as a part of “current GMP” systems which can only be imparted through an effective ongoing training program with proper evaluation system in place.

 

REFERENCES:

1.     Personnel responsibilities, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.28. Accessed on 15/05/2016.

2.     https://en.wikipedia.org/wiki/Hygiene. Accessed on 05/06/2016.

3.     cGMP guidelines for pharmaceutical industries, http://www.pharmaguideline.com/2011/07/cgmp-part-1.html. Accessed on 15/07/2016.

4.     Good manufacturing practices for pharmaceutical products: main principles. http://apps.who.int/prequal/info_general/documents/TRS908/WHO_TRS_908-Annex4.pdf. Accessed on 10/08/2016.

 

 

 

Accepted on 29.10.2016           © RJPT All right reserved

Research J. Pharm. and Tech 2016; 9(10):1647-1649.