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1. Name of the Topic: Organization and Personnel: Personnel
Responsibilities, Training, Hygiene and Personnel Records
Examination: 1st Continuous Assessment (1st CA)
Name: Suvojit Basak
Roll Number: 35601921045
Registration Number: 213560201910045
Semester: 6th
Year: 3rd
Subject: Quality Assurance
Paper Code: PT 611
Academic Session: 2023-2024
Global College of Pharmaceutical Technology
(A Unit of National Centre for Development of Technical Education)

2. Organization and Personnel: Personnel Responsibilities, Training, Hygiene
and Personnel Records
 Organization:
In pharmaceutical quality assurance, an organization refers to the structured entity responsible for
establishing and implementing quality management systems to ensure the safety, efficacy, and compliance of
pharmaceutical products with regulatory standards. This includes defining roles, responsibilities, processes, and
protocols to maintain the highest quality throughout the entire product life cycle.
 Personnel:
• The establishment & maintenance of a suitable quality assurance system for pharmaceutical products depends on
the person & ‘A’ person who is responsible for manufacturing, processing, packaging & handling of drug products
should be provided with adequate education, training and experience is defined as personnel.
• Personnel is the most significant part of a manufacturing system. Thus, they should be provided with standard
training to maintain a high level of safety, identity, strength, quality & purity in the work area.

3.  Personal Responsibilities:
1. Personnel involve in manufacturing, processing, packing and handling of drug products should wear clean
clothing or uniform. The personnel should cover his/ her head, face, hand and arms in order to protect.
2. The company should provide appropriate uniform or protection clothing to the personnel.
3. The personnel should follow the good sanitisation & healthy habits.
4. Personnel should not wear any jewellery or make-up in production or quality control areas because it may leads to
contamination issues.
5. Eating, drinking, chewing, alcohol, smoking, medicines should not be allowed in production & storage area.
6. Only authorised and suitable trained personnel should enter the company areas. If any person who is not the
employee of company need to work or enter those areas first, they should receive minimum training.
7. Personnel should be physically fit to work. Tests should be conducted on regular bases.
8. An employee who was not present due to illness should report to company’s medical facility before reporting to
work in their functional area.
9. In case of an equipment malfunction or process deviation, the personnel should immediately report it to the
supervisor.

4.  Training:
• The manufacturer should provide training in accordance with a written programme for all the employees or
personnel whose duties take personnel into manufacturing area or into control laboratories.
• Newly recruited personnel should receive training appropriate to the duties assigned to them.
• Personnel working in areas where highly active, toxic, infectious or sensitizing material are handled, personnel
should be given specific training.
• The concept of quality assurance should be fully discussed during the training sessions.
• Continuing training should be given & it’s practical effectiveness periodically evaluated.
• Staff should be qualified for the services they provide to personnel.
• Training records should be kept & maintained.

5.  Hygiene:
• All personnels should be trained in the personnel hygiene. A high level of personnel hygiene should be observed by
the personnel working in company.
• All personnel should undergo health examination.
• Personnel should be instructed to wash their hands, before entering production areas.
• Smoking, eating, drinking, chewing, smoking or medicines should not be permitted in production, laboratory &
storage areas.
• Direct contact should be avoided between the starting materials, primary packaging materials, intermediate & bulk
products.
• To protect the products from contamination, personnel should wear clean body covering appropriate to their duties.
• Protective clothing should apply to all persons entering production areas, whether they are temporary or fulltime
employees.
• If personnel show any illness sign, then personnel is not allowed to handle, starting material, packaging material,
in process material until the condition is no longer judge to be a risk.
• Personnel should be instructed & encouraged to report their supervisor in any mistake or condition.
• Personnel’s used clothes, if reusable then store the clothes in separate closed containers until properly laundered.

6.  Personnel Records:
Personnel record is a statement describing an event, situation & happening in a clear
manner.
 Importance:
• It provide both qualitative & quantitative information as to what happened & what is happening.
• Records are factual & comprehensive information.
• Records keep an update records of leave, lockout, transfer, turnover etc. of the employees.
• Records helps the manager in farming various training & development programmes on the basis of present
scenario.
• Record helps the manager to make salary & other benefits related to salaries.