Welcome to Marya

info@marya.cn

marya

Company News

Industry Information

Production Management of GMP Manual

2022-03-10

Original

Marya

 Questions and Answers ...................................................................................................................................................................

 

 

1.What’s the main contents of technological procedure、post operation method and standard operating procedures(SOP)?

A:The contents of production technological procedure include:trade name, dosage form, prescription, operational requirements of the production process, materials, intermediate products, finished product quality standards, technical parameters and storage precautions, calculation method of material balance, requirements for finished containers and packaging materials, etc.

The contents of post operation method include: production operation method and main point, key operation’s re-check and review, quality standard and control of intermediate products, safety and labor protection, facilities maintenance、clean, abnormal situation handling and reporting, process hygiene and environmental hygiene.   

The contents of standard operating procedures include: title, number, author and date of formulation, reviewer and date of review, approver and date of approval, issuing department, production date, distribution department, title and text.   

 

2. What is the content of batch process record?

A: The content of batch process record includes: products name, production batch, operator, signature of reviewer, the number of products in the relevant production stage, the calculation of material balance, the monitoring record of the production process and the record of special problems.

 

3.What are the requirements of making production management document and quality management document?

A: The requirements of making production management document and quality management document are:

  1. Document title should clearly explain the document’s property;
  2. Various documents should have the system code and date for easy identification of style and category;
  3. The language documents use should be precise and easy to understand;
  4. There should be enough blank in the time of filling in date;
  5. Responsibilities for document formulation, review and approval should be clear and signed by the responsible person.

 

4.What are the requirements when filling in batch process records? How long is it kept?

A: The batch process record should be clearly written, true in content, complete in data, and signed by the operator and reviewer. Records should keep clean, and can’t be torn up and arbitrarily altered. When changing the records, please sign in the changed place, and let the original date can be recognized.

The batch process record should be archived by batch number, and kept until one year after the expiry date of the drug. For drugs with no expiry date, the batch process records shall be kept for at least three years.

 

5.How to avoid drugs be polluted and mixed in the production operation process?

A: To avoid drug be polluted and mixed, production operation process should take the following measures:

  1. Before production, it should be confirmed that there are no remnants from the previous production;
  2. Avoiding dust produces and diffuses;
  3. The production operations of different product varieties and specifications shall not be carried out simultaneously in the same production operation. When there are several packaging lines for packaging at the same time, isolation or other facilities that effectively prevent pollution and confusion should be adopted.
  4. During the production process, prevent cross-contamination caused by gas, steam, spray or organisms produced by materials and products;
  5. Each production operation room or production equipment and container should have status signs such as the name, batch number, and quantity of the product or material produced;
  6. After picking, the medicinal materials should be washed with running water, and the used water shall not be used for washing other medicinal materials. Medicinal materials of different medicinal properties shall not be washed together. The cleaned medicinal materials and cut and processed products are not allowed to be dried in the open air.

The sterilization methods of medicinal materials and their intermediate products should be based on the principle of not changing the efficacy and quality of the medicinal materials, and the medicinal powders that are directly used as medicines should be subjected to microbiological examination before compounding.        

 

6.What’s the content of batch packaged record?

A: The content of batch packing record includes:

  1. The name, batch number and specification of the batch packaged product;
  2. Label with batch number and instruction manual and product certificate;
  3. The number of products to be packaged and packaging materials received and the signatures of the issuer, recipient, and verifier;
  4. Number of packaged products;
  5. The site-clearing record (copy) of the previous packaging operation and the site-clearing record of this packaging (original);
  6. The inspection result and the signature of the verifier after the packaging operation is completed
  7. Signature of the person in charge of production operations

 

7.How to fill in the site-clearing record? What is the content of the site-clearing record?

A: After each production stage of each batch of drugs is completed, the production operator must clear the site and fill in the site-clearing record. The content of the site-clearing record includes: process, product name, production batch number, site- clearing date, inspection items and results, signature of the person in charge of site-clearing and reviewer. Site-clearing records should be brought into batch process records and enclose site-clearing certificate of conformity. The site clearance records of the packaging process are the original and the duplicate. The original shall be included in the current record, and the duplicate shall be included in the batch record of the next shift. Only fill in one site clearance record for other processes.The site-clearing records of the packaging process are the original and the duplicate. The original shall be included in the current record, and the duplicate shall be included in the batch record of the next time. Other processes only need to fill in one site-clearing records

 

8.What’s the principle of batch division?

A: A certain number of drugs that have the same nature and quality within the specified limits and are produced in the same continuous production cycle are a batch.

(1)The solid and semi-solid preparations of non-sterile drugs are formed or divided into a batch of homogeneous products produced by the same mixing equipment at one time. If using fractional mixing, it has been verified that a certain amount of homogeneous products produced within the specified limit is a batch

Liquid preparation: a batch of homogeneous products produced by the last mixed liquid medicine before filling (sealing)

⑵The large and small container injections in sterile medicines are a batch of homogeneous products produced by the same liquid preparation tank. Powder injection is a batch of homogeneous products produced by the same batch of raw materials in the same continuous production cycle. The freeze-dried powder injection is a batch of homogeneous products produced in the same production cycle。

(3)The principle of dividing the batch of APIs is divided into two situations: ①For continuous production of APIs, the number of homogeneous products produced within the specified limit within a certain time separation is a batch.②For batch-produced APIs, a batch of homogeneous products within specified limits obtained by final mixing of a certain number of products.

 

9.What are the methods of processing Chinese medicinal materials?

A: The processing methods of traditional Chinese medicinal materials can be divided into: net selection,washing ,cutting, steaming,frying(including roasting), calcining, etc. The processing is carried out according to the technological requirements, and the processing is based on the Chinese Pharmacopoeia and Henan Province.

 

10.What is the purpose of traditional Chinese medicine processing?

A: The purpose of traditional Chinese medicine processing is to reduce or eliminate the toxicity or side effects of the drug,change or alleviate the drug propertises; improve the curative effect,change or enhance the site and tendency of drug action;facilitate dispensing and preparation; ensure drug cleanliness,facilitate storage, facilitate taking.

 

11.In addition to the contents of question 36, what else should be included in the batch production record?

A: It should also include:production instructions, a copy of the last production site clearance, material weighing records(material batch number, quantity),intermediate product inspection reports and turnover records, finished product storage records, records automatically printed by production equipment or facilities(automatic weighing records,automatic temperature control),the production plant environment is temperature,humidity, pressure difference and other on-site records, cleaning and site clearance records, process verification, deviation analysis, finished product inspection report, product release audit form, etc.

 

12.Do the batch production records include the inspection records of raw and auxiliary materials and packaging materials?

A: In the batch production record, for the raw materials, auxiliary materials,and packaging materials used, it is required to record the inspection report number.According to the inspection report number,the incoming inspection of the material can be tracked. Therefore, the general inspection record is not included in the batch production record.

 

13.How to handle the material balance beyond the limit in production?

A: When the balance calculation result exceeds the specified limit, the process investigation must be traced from the starting material. Only when the investigation results can prove that there is no error and the survey results can be recorded before the next process can produce or determine the product is qualified.At the same time, the causes are evaluated and analyzed, and revised the balance limit if necessary.

 

14.What are the requirements for water for pharmaceutical process?

  1. The drinking water shall comply with the Ministry of Health Living Water Standard GB4750-85. (Testing by epidemic prevention department )
  2. Purified water shall comply with the Chinese pharmacopoeia standard.
  3. Injection water shall meet the Chinese pharmacopoeia standard.

 

15.What are part of the daily inspection items for drinking water, purified water, and injection water?

  1. Daily conductivity inspection for drinking water.
  2. Purified water was checked daily for PH, chloride, ammonia salts, heavy metals, and electrical conductivity.
  3. In addition to the above five items, bacterial endotoxins and microorganisms should also be checked once a day.

 

16.What should I pay attention to when storing the injection water?

A: The hydrophobic filter must not be installed at the tank vent for injection water.The storage of water for injection can be kept at a temperature above 80℃，circulated at at temperature above 65℃，or stored at a temperature below 4℃.