What problems may arise in the chemical supply?

In the process of supplying chemical drugs, common problems are concentrated in three categories: supply guarantee, circulation management, and quality and safety, as follows:
1、 The problem of supply interruption and shortage on the supply side
This is the most prominent issue in clinical and production settings, with core reasons including:
The supply of upstream active pharmaceutical ingredients is limited: some active pharmaceutical ingredient production capacity is concentrated, and there are situations such as monopoly sales control, environmental protection production restrictions, and enterprise transformation and shutdown, which can directly lead to the interruption of downstream formulation supply. For example, the cefmetazole sodium injection selected in centralized procurement was once interrupted due to the inability to supply upstream active pharmaceutical ingredients; Emergency rescue drugs such as protamine and chlorfenapyr are often in short supply due to rising raw material costs and decreased supply willingness from enterprises.
Mismatch between centralized procurement policy and production capacity: Some selected enterprises' production capacity cannot meet the agreed purchase quantity, or the procurement price is too low, resulting in inverted profits and insufficient production enthusiasm, ultimately leading to supply interruption. There have been cases of centralized procurement of selected drugs in many places such as Zhejiang and Hebei.
Long approval cycle for changes: When a company needs to change its raw material supplier, it needs to reapply to the drug regulatory department for approval and go through the process. If the raw materials are not connected during the approval period, there will be a temporary interruption in supply.
2、 The problem of non-standard management in the circulation process
Common common issues during inspections include:
Lack of personnel qualification review: Failure to strictly review the identity certificates of the purchasing, picking up, and receiving personnel of the purchasing unit, such as lack of authorization letter, authorization letter not stamped and signed, and inconsistency between the recipient of special drugs and the authorized personnel.
Vulnerabilities in entrusted transportation management: The quality assurance capability of the carrier has not been audited, there is a lack of transportation facilities, equipment, and personnel qualification information, the entrusted transportation agreement does not clearly define drug quality responsibilities and transit time limits, and transportation records often lack key information such as shipment information and license plate numbers.
Chaotic after-sales and return management: no dedicated person is responsible for after-sales complaints, and there is a lack of complete complaint operation procedures; Partial returned drugs cannot provide return vouchers, cold chain returns lack temperature records, and acceptance sampling does not meet the requirements.
3、 Quality and traceability safety issues
These types of issues will directly affect the safety of drugs:
Quality risks in the storage and transportation process: collision and compression during transportation can cause damage to drugs, inadequate storage or transportation temperature and humidity can lead to drug deterioration, and there may also be hidden dangers such as wrong or missed delivery, mixing of counterfeit and inferior drugs, and contamination during transportation.
Change filing and research non-compliance: When applying for changes in raw material drug suppliers, there are often problems such as lack of proof materials for new suppliers, failure to conduct quality comparison studies as required, incomplete stability test data, inconsistent standard implementation, etc., which may lead to deviations in the quality of the formulation.
Quality non-compliance issues: During sampling, it is often found that chemical drugs have issues such as pH value, insoluble particles, visible foreign objects, dissolution rate, and excessive related substances. For example, sodium bicarbonate injection and coenzyme Q10 injection have been reported as non compliant in multiple projects.
Incomplete traceability information: Some supply process traceability records are incomplete, making it difficult to achieve full chain traceability and quickly identify and recall problems.