Each province、Autonomous Region、Food and Drug Administration (Drug Supervision Administration):

Recently, the problem of chromium over -standard drugs reflects the weak quality management of some pharmaceutical manufacturers，Especially reflected in the inspection of supplements and finished products，Some companies cannot conduct a batches in accordance with relevant regulations，As a result, the unqualified original auxiliary materials are put into use，Unqualified products flow into the market，Harmly public interest。To ensure the medicine、Health food quality and safety，Practical strengthening medicinal gelatin、Pharmaceutical capsules、Quality management and inspection work of stake online sports bettingCapsules drugs and health food manufacturers，The relevant matters are notified as follows:

1. Improve the requirements of the production enterprise quality management system

Medicinal Glipper、Pharmaceutical My stake betting appcapsules、stake online sports bettingCapsules drugs and health food manufacturers should improve the enterprise quality management system，Ensuring the effective performance of quality assurance and quality control of the quality management department。The person in charge of the enterprise and other departments shall not interfere or hinder the quality management department to perform their duties。The determination and changes of the material supplier shall be conducted for quality assessment or auditing，and approved by the enterprise quality management department。

    Medicinal Glipper、Medicinal Capsules and Capsules Drugs must be inspected before the factory is sold and should meet the relevant national standards。Capsules Health Foods should be tested in accordance with the product quality and safety requirements before the factory is sold and should meet the relevant national standards。Before the product release，All production documents and records，Including the inspection data shall be reviewed by the quality management department and meets the requirements。Unqualified products must not be released from the factory。

2、Enhanced the relevant requirements of the quality management and inspection of medicinal gelatin production

Pharmaceutical gelatin manufacturers shall formulate materials for production for production、Storage、Use and other management systems; raw materials (leather should be developed、Bone、tendon) Quality Standards，and filed with the provincial food and drug regulatory authorities。Enterprises should test raw materials in accordance with quality standards，To ensure the quality requirements of the raw material to meet the quality of the pharmaceutical gelatin。Check the qualified raw materials to be used for use。

Enterprises shall regulate the batch number of pharmaceutical gelatin，For the actual production of the company，stake online sports bettingFormulate My stake betting appmanagement regulations for batch number preparation。Each batch of products must be a homogeneous product that meets the requirements of quality and characteristics。To ensure the homogeneity of the quality and characteristics of the same batch of products，The division of the batch of gelatin production，Generally, a batch number should be used in a mixed jar to regulate the product。

Enterprises shall conduct a full test of each batch of medicinal gels in accordance with the "Chinese Pharmacopoeia" (2010 version) standard，Only after qualified、Sales。

3、Related requirements for the quality management and inspection of medicinal capsules

Pharmaceutical capsule manufacturers must purchase pharmaceutical gelatin。It is strictly forbidden to buy non -medicinal gelatin for production。Enterprises shall conduct a full test of each batch of medicinal gels purchased in accordance with the "Chinese Pharmacopoeia" (2010 version) standard，Only after qualified、Pack。

Enterprises should standardize the batch number of medicinal capsules，For the actual production of the company，stake online sports bettingFormulate My stake betting appmanagement regulations for batch number preparation。Each batch of products must be a homogeneous product that meets the requirements of quality and characteristics。To ensure the homogeneity of the quality and characteristics of the same batch of products，Division of the production batch of medicinal capsules，Generally batch number of the same raw material、The same formula、The same specification、Nissan or class output of the same process is a batch number。

Enterprises shall conduct a full test of each batch of medicinal capsules in accordance with the "Chinese Pharmacopoeia" (2010 version) standard，Only after qualified、Sales。

4、Related requirements for strengthening the quality management and inspection of capsules

Capsules medicine、Health food manufacturers must purchase products from enterprises with medicinal capsules approved number。Enterprises should conduct a full test of each batch of medicinal capsules purchased in accordance with the standard of "Chinese Pharmacopoeia" (2010 version)，Only after qualified、Use。

Enterprises shall conduct a full test of each batch of capsule agent drugs in accordance with national drug standards，Only after qualified、Sales。

5. Standardize the relevant requirements for entrustment inspection

Medicinal Glipper、Pharmaceutical capsules and capsule agent drug manufacturers must stake betting appbe equipped Stake Sports Bettingwith inspection instruments and inspectors that are compatible with the products produced。Before September 30, 2012，Individual inspection items can adopt a commission inspection method。The client and the trustee must sign a written contract，Determine the responsibility of all parties、The content of the entrusted inspection and related technical matters。The client should evaluate the trustee，Conditions for the recipient、Technical level、Quality management situation conducts on -site assessment，Confirm that it has the ability to complete the testing task。Food and Drug Supervision Department has the right to supervise and inspect the trustee。Production companies that adopt the entrusted inspection method must have the ability to conduct full inspection of the products produced as soon as possible，From October 1, 2012，No commissioned inspection。

The above requirements will be implemented from May 1, 2012。Enterprises that are not in the above requirements，Stop production of related products，Until it meets the requirements, it can be restored to production。Food and drug supervision departments at all levels should increase the pharmaceutical gelatin、Pharmaceutical capsules、Supervision and inspection and testing of stake online sports bettingCapsules drugs and health food manufacturers，Anyone who discovered the company's illegal production，Resolutely investigate and deal with it in accordance with the law。

                                                                  National Food and Drug Administration
                                                                  April 28, 2012