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GMP Information Handbook: Equipment Maintenance and Quality Management

2022-03-16

Original

Marya

 Quastions and Answers ...................................................................................................................................................................

 

 

1. What is the principle of manufacturing safety?

Safety is foremost, prevention is fundamental.

 

2. What are the five FIXED in equipment lubrication?

Fixed place, fixed quality, fixed amount, fixed schedule, fixed personnel.

 

3. What are four criteria of equipment maintenance?

Organized, clean, lubricated, safe.

 

4. What are the five principles of equipment operation?

  1. Operation can only be performed by certified operators following safety operation regulations.
  2. Equipment should be kept clean at all times, and lubricated according to regulations.
  3. Take good care of tools and accessories, and store them properly.
  4. Take good care of tools and accessories, and store them properly.
  5. In case of equipment malfunction or failure, immediately shut down the equipment, and call for thorough inspection for cases that cannot be handled.

 

5. What are the basic skills and knowledge in equipment operation and maintenance?

Skills to keep it properly, operate it properly, maintain it properly.

Basic operation knowledge, basic maintenance knowledge, basic examination knowledge, basic troubleshooting knowledge.

 

6. What is the main function of a steam trap? Why is installed and when is it used?

A steam trap is designed to “trap” the steam and drain the condensate water.

The installation of the bypass valve is for the intermittent heating equipment, in order to improve its thermal efficiency, the condensed water and non-condensable gas accumulated in the system should be quickly removed at the beginning of use. When the equipment is started and stable steam is observed, the bypass valve should be closed and the steam trap is automatically put into operation.

 

7. What are the factors affecting the energy utilization rate in an enterprise?

Main factors include:

(1) The function and productivity of the equipment;

(2) Energy conversion efficiency of the equipment;

(3) Management factors; examine and prevent off-tracking, dripping or leaking.

 

8. What requirements should pharmaceutical equipment meet?

All surface in direct contact with the medicine of the pharmaceutical equipment should be smooth, flush, easy to clean or sterilize, corrosion-resistant, and cannot absorb or react with medicine chemicals. Lubricants, coolants used in the equipment must not contaminate medicine or containers.

 

9. What are the different types and grades of stainless steel used in pharmaceutical equipment?

  1. Ordinary stainless steel, containing chromium, nickel and titanium (1Crl8Ni9Ti),  a relatively higher carbon content;
  2. 304L stainless steel, containing chromium, nickel and titanium (0Crl8Ni9Ti), a slightly lower carbon content;
  3. 316L stainless steel, containing chromium, nickel, titanium and molybdenum (00Crl8Ni9TiMo), a low carbon content.

 

10. Why is measurement important in an enterprise?

Measurement is involved in business management, process control, testing, safety protection, environmental monitoring, trade settlement and other processes. Without accurate measurement data, there will be no reliable basis for decision-making in an enterprise. Therefore, the measurement is not only important to the establishment and operation of an enterprise's quality system, but also plays an important role in supporting and guaranteeing all work in an enterprise. According to GMP requirements, all measuring equipment (weighing instruments, scales, pressure gauges, flow meters, thermometers) must be verified and labeled by the Technical Supervision Bureau before it is put into use. The precision instruments (thin-layer scanner, high performance liquid chromatography, etc.) need to be verified by the Provincial Technical Supervision Bureau before it is put into use.

 

11. What is Cleaning in Place (CIP)?

Cleaning in place (CIP) refers to the cleaning of the production system or equipment without dismantling or opening of the equipment or changing its location.

 

12. What Is Sterilization in Pace (SIP)?

Sterilization in Pace (SIP) refers to the steam sterilization of the production system or equipment without dismantling or opening of the equipment or changing its location.

 

13. How are pipes color coded?

Main fixed pipes should be clearly labeled to indicate the contents and the direction of flow. Pipes are color painted to indicate different contents: water in green pipes, steam in red pipes, materials in yellow pipes.


14. What are the requirements for the person in charge of the quality management department?

According to the requirements of GMP, pharmaceutical enterprises should establish a quality management organization, which is directly under the leadership of the person in charge of drug quality management in the enterprise. The person in charge of the quality management department must have a college degree or above in medicine or related majors and corresponding professional qualifications and titles. The persons in charge of the production department and quality departments shall not serve concurrently.

 

15. What is the difference between quality inspection and quality supervision?

The traditional quality inspection is only an inspection of the finished products, and cannot control the circulation of unqualified products at the source. Quality supervision is the supervision and control of the entire production process. Therefore, there is a fundamental difference between these two roles.

 

16. What are the responsibilities of the Quality Assurance Department?

  1. Quality supervision; monitoring the entire production process of each workshop, from raw materials, auxiliary materials, packaging materials to intermediate products and finished products.
  2. Quality inspection: Quality inspection of central laboratory and workshop laboratory.
  3. Quality management: establishment of product quality standards, sample observation, product quality analysis, and handling of quality accidents during user visits and supplier inspections.
  4. Quality documents: Quality information and records of all products should be clearly documented and systematically managed.
  5. Quality training: Provide quality training and education to quality supervisors and personnel.
  6. Animal laboratory management.

 

17. What is the difference between a quality supervisor and a chemical analyst?

The quality supervisor is responsible for the supervision and inspection of the whole production process from ingredient feeding, and keeping production records, etc. The chemical analyst use physical and chemical methods to inspect raw and auxiliary materials, packaging materials, intermediate products and finished products, and then issue inspection reports. The purpose of the two roles is the same, but the job responsibilities are different.

 

18. How to determine the sample size of the raw materials of Traditional Chinese Medicine?

The total amount of medicinal materials is n, when n≤5 pieces, sample each piece; when 6≤n≤100, sample 5 pieces; when n=100～1000pieces, sample size should be 5%; For high value medicinal materials, sample each piece.

 

19. What are the two categories of production quality accidents?

Production quality accidents are divided into 2 categories: major damage accidents and general accidents.

Major damage accidents: The amount of economic loss caused by the quality problem is greater than 50,000CNY, including the return of medicines and claims within the warranty period of the pharmaceutical factory.

General accidents: The economic loss caused by the quality problem is more than 5,000CNY.

 

20. What 3 things should be conducted thoroughly after an accident?

(1) A thorough analysis of the cause of the accident;

(2) Thorough education or training given to the person held responsible and ;

(3) Preventative measures thoroughly implemented.

 

21. Why are the internal control standards of enterprises higher than statutory national standards?

The statutory national standards stipulate the minimum requirements that medicine must meet. However, in order to ensure the quality of the manufactured products, the enterprise can set higher quality standards than the national standards according to the actual situation of the enterprise. However, in case of arbitration, the quality of the manufactured products is based on the national standards.

 

22. What are the different categories of user complaints?

User complaints are divided into:

Category A: Complaints about quality problems that will NOT cause adverse drug reactions. They include misunderstandings caused by changing the outer packaging, minor outer packaging damage, packing quantity shortage, etc.;

Category B: Complaints about quality problems resulting adverse reaction that will not endanger or harm life but cause user anxiety, mild allergic reactions or stable decline of drugs. Or there are complaints of serious bad quality package, etc.;

Category C: Complaints about quality problems that may harm the user's health or threaten the user's life, such as dose errors, drug deterioration, mislabeling, severe allergies or other side effects.

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