112 Basic GMP Knowledge Q&As（Q63-85）

Over the next month, we will share 112 Basic GMP Knowledge Q&As, Please subscribe to our GMP EXPLAINED

63. What is the eight-character guideline for production safety?

Answer: Safety first, prevention foremost.

64. What are the "five determinations" of equipment lubrication?

Answer: Specified location, quality, quantity, timing, and personnel.

65. What are the four requirements for equipment maintenance?

Answer: Tidiness, cleanliness, lubrication, safety.

66. What are the "five disciplines" of equipment operation?

Answer: ⑴ Use equipment with an operation permit, comply with safety operation procedures; ⑵ Keep equipment clean regularly and lubricate as specified; ⑶ Follow the shift handover system; ⑷ Manage tools and accessories properly, do not lose them; ⑸ In case of anomalies, stop the machine immediately, if unable to handle the issue, notify for inspection promptly.

67. What do the "three goods" and "four abilities" refer to in equipment use and maintenance work?

Answer: The "three goods" refer to: good management, good usage, good repair. The "four abilities" refer to: the ability to use, maintain, inspect, and troubleshoot general faults.

68. What is the purpose of a steam trap? Why is a bypass valve needed when installing a steam trap? When is it used?

Answer: Its purpose is to block steam and drain water. Installing a bypass valve is because, for intermittent heating equipment, to improve thermal efficiency, it's necessary to quickly drain accumulated condensate and non-condensable gases at the start, to enhance the thermal efficiency of the heating equipment. The bypass valve is opened only at the start, and once stable steam discharge is observed, it is closed, and the steam trap automatically begins to work.

69. What factors affect the energy utilization rate of a company?

Answer: Mainly include: ⑴ Performance and efficiency of equipment; ⑵ Energy conversion efficiency of equipment; ⑶ Management factors; presence of leaks, drips, and other losses.

70. What requirements should pharmaceutical equipment meet?

Answer: Surfaces that directly contact drugs should be smooth, flat, easy to clean or sterilize, corrosion-resistant, and not chemically react with or adsorb drugs. Lubricants, coolants, etc., used in the equipment must not contaminate the drugs or containers.

71. What are the materials of stainless steel used in pharmaceutical equipment?

Answer: ⑴ Ordinary stainless steel, consisting of chromium, nickel, titanium (1Cr18Ni9Ti) with a slightly higher carbon content; ⑵ 304L stainless steel, consisting of chromium, nickel, titanium (0Cr18Ni9Ti) with lower carbon content; ⑶ 316L stainless steel, consisting of chromium, nickel, titanium, molybdenum (00Cr17Ni14Mo2) with the lowest carbon content.

72. Why is measurement work considered an important task for enterprises?

Answer: Because it involves business management, process control, testing, safety protection, environmental monitoring, trade settlement, etc. Without accurate measurement, there would be no reliable data, and thus no basis for enterprise decision-making. Therefore, measurement work not only supports and guarantees the establishment and operation of the enterprise's quality system but also its entire operation. According to GMP requirements, all measuring devices (scales, balances, pressure gauges, flow meters, temperature gauges) in an enterprise must be calibrated by the Bureau of Technical Supervision, and a qualification sticker must be attached before use. Precision instruments (thin-layer chromatographs, high-performance liquid chromatographs, etc.) must be calibrated by the Provincial Bureau of Technical Supervision before use.

73. What is online cleaning?

Answer: Refers to cleaning the production system or equipment without moving it from its original installation position.

74. What is online sterilization?

Answer: Refers to sterilizing the production system or equipment with steam without moving it from its original installation position.

75. How should equipment pipelines be painted?

Answer: The main fixed pipelines connected to the equipment should indicate the name of the material inside and the direction of flow. Different materials are managed by using different colors to distinguish them: water pipelines are green, steam pipelines are red, and material pipelines are yellow.

(Section VIII) Quality Management

76. To whom does the quality management department belong, and what are the requirements for its leader?

Answer: According to GMP requirements, pharmaceutical enterprises should establish a quality management institution, directly led by the person in charge of drug quality management in the enterprise. The head of the quality management department must have a college degree or above in medicine or a related field and corresponding professional and technical titles. The heads of production and quality departments cannot hold the same position.

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

Answer: Traditional quality inspection is just a gatekeeping inspection of finished products, which cannot prevent the flow of non-conforming products at the source. Quality supervision, on the other hand, is the supervision and control of the entire production process, so there is a fundamental difference between the two.

78. What is the scope of responsibilities of the quality assurance department?

Answer: ⑴ Quality supervision; monitoring of the entire production process in various workshops, from raw materials, auxiliary materials, packaging materials to intermediate products and finished products. ⑵ Quality inspection: Quality inspection in the central laboratory and workshop laboratories. ⑶ Quality management: Formulation of product quality standards and sample observation, product quality analysis, customer visits, supplier evaluation, and handling of quality incidents. ⑷ Quality records: Establishing quality records for all products and managing them systematically. ⑸ Quality training: Quality training and education for quality inspectors and employees. ⑹ Management of the animal experimentation laboratory.

79. What is the difference between a quality inspector and a laboratory technician?

Answer: Quality inspectors are responsible for supervising and inspecting the formulation, production records, and the entire production process. Laboratory technicians use physical and chemical methods to inspect raw and auxiliary materials, intermediate products, and finished products, and issue inspection reports. While their purposes are the same, their work is different.

80. How is the sampling quantity of incoming traditional Chinese medicinal materials calculated?

Answer: When the total number of batches n≤5, sample each batch; n≤100, sample 5 batches; n=100～1000, sample 5% of the batches, and for expensive medicinal materials, sample each batch.

81. How are samples of raw materials and auxiliary materials taken? Answer: For a total number of batches n≤3, sample each batch; n=4～300, sample ; n＞300, sample .

82. How are production quality incidents classified?

Answer: Production quality incidents are classified into: major incidents and general incidents. Major incidents: Incidents that cause an economic loss of 50,000 yuan or more at one time, including returns and claims for drugs within the factory's responsibility period. General incidents: Incidents that cause an economic loss of 5,000 yuan or more at one time.

83. What does "three non-exemptions" in the event of an incident refer to?

Answer: ⑴ Not exempting from further action until the cause of the incident is clearly analyzed; ⑵ Not exempting from further action until the responsible individuals and the public are educated; ⑶ Not exempting from further action until preventive measures are in place.

84. Why are enterprise internal control standards higher than statutory standards?

Answer: National standards set the minimum standards that drugs must meet. However, enterprises can formulate quality standards higher than national statutory standards based on actual conditions, which serve as corporate regulations. When the quality of factory products needs to be arbitrated, legal standards will still be the basis.

85. How are customer complaints classified?

Answer: Customer complaints are classified into: Class A: Quality issue complaints that will not cause adverse drug reactions, such as misunderstandings due to packaging changes, minor damage to packaging, short shipments, etc.; Class B: Complaints about adverse reactions that will not endanger or harm life but cause customer discomfort, or serious appearance quality issues, such as mild allergic reactions or drug stability decline, etc.; Class C: Quality issue complaints that may harm the health of users or threaten their safety, such as dosage errors, drug deterioration, mislabeling, severe allergies, or other side effects, etc.

#GMPInsights #QualityAssurance #PharmaGMP #GMPCompliance #DrugSafety #GMPStandards hashtag#Pharmaceuticals #QualityControl #GMPTraining #GMPExplained #HyperchemGMP

?