I.
Operating procedures should be developed to ensure that the quality authorized person to independently perform their duties without interference from the person in charge of the enterprise and other personnel.
(Article 20) SOP for the independent performance of duties by the quality authorized person
II.
Enterprises shall establish operating procedures for personnel hygiene, including those related to health, hygiene practices and personnel dress; measures shall be taken to avoid personnel with wounds on the surface of the body, infectious diseases, or other diseases that may contaminate the medicines from engaging in the production of medicines that come into direct contact with the medicines. (Articles 29, 30, 32) Personnel Hygiene SOP
III.
Appropriate maintenance of the plant should be carried out and it should be ensured that the maintenance activities do not affect the quality of the medicines. The plant should be cleaned or disinfected as necessary in accordance with detailed written operating procedures. (Article 41) SOP for Cleaning and Disinfection of Plant
IV.
Operating procedures for the use, cleaning, maintenance and repair of equipment should be established and appropriate operating records should be kept. (Article 72) equipment use, cleaning, maintenance and repair SOP
V.
Production mold procurement, acceptance, storage, maintenance, issuance and scrapping should be set up accordingly operating procedures, set up a special cabinet for storage, and keep appropriate records. (Article 78) production mold procurement, acceptance, storage, maintenance, issuance and scrap SOP
VI.
Preventive maintenance of equipment should be formulated and operating procedures, maintenance and repair of equipment should have corresponding records. (Article 80
) in which the equipment code is important to see which equipment in which room, process procedures, batch production records should be reflected. Preventive maintenance programs and SOPs for equipment
VII.
The main production and inspection equipment should have operating procedures, production equipment should also have cleaning procedures. (Article 82, 84) for production or inspection equipment and instruments, there should be a logbook, including the use, cleaning, maintenance and repair and date and time
time, the production and inspection of the name of the drug, specifications and batch number. (Article 86) the main production and inspection equipment SOP / use log, production equipment cleaning SOP
eight,
should be in accordance with operating procedures and calibration plan for production and inspection of scales, gauges, meters, recording and control equipment and instruments regularly calibrated and inspected, and keep records. (Article 90) SOPs for calibration and inspection of scales, gauges, meters, recording and control equipment, and instruments
IX.
Pipelines for purified water and water for injection shall be cleaned and disinfected in accordance with operating procedures and records shall be kept. (Article 101)
SOP for cleaning and disinfection of purified water and water for injection pipelines
X.
Operating procedures for materials and products should be established to ensure the proper receipt, storage, issuance, use and shipment of materials and products. Handling of materials and products should be carried out in accordance with the operating procedures or process procedures, and records. (Article 103) SOP for the receipt, storage, issuance, use and shipment of materials and products
XI.
The receipt of raw and auxiliary materials, packaging materials in direct contact with pharmaceutical products and printed packaging materials should have operating procedures. (Article 106)
Packaging materials should be issued by a person in accordance with the operating procedures, and take measures to avoid measures and errors. (Article 121) SOP for Receiving and Issuing of Raw and Auxiliary Materials, Packaging Materials in Direct Contact with Drugs, and Printed Packaging Materials
XII.
Corresponding operating procedures shall be established, and appropriate measures such as checking or inspection shall be taken to confirm that the raw and auxiliary materials in each package are correct.
(Article 11) can be used in the sequential number checking, near infrared detection, Raman spectroscopy (with spectral maps), ingredients weighing test and other methods
methods. Confirmation of the correct raw and auxiliary materials in each package SOP
thirteen,
Should be designated personnel in accordance with operating procedures for the dosage, after checking the material, accurate weighing or calculation. And well labeled.
(Article 115) dosing, checking, weighing SOP
XIV, should establish operating procedures for the design, review and approval of printed packaging materials, including changes in the version of printed packaging materials.
(Articles 122 and 123) SOP for design, review and approval of printed packaging materials
XV.
Return of goods operating procedures, including at least the following: product name, batch number, specifications, quantities, the return unit and address, the reason for the return of goods and the date of return, and the final disposition of the opinion. (Article 136) SOP for Returned Products, SOP for Repackaging and Shipping of Returned Products
XVI.
Returned products may be considered for repackaging and reshipping for sale only if there is evidence that the quality of the returned products has not been affected after inspection, examination and investigation, and if they have been evaluated by the quality management department in accordance with the operating procedures. (Article 137)
XVII.
Confirmation and validation documents and records (including validation master plan, confirmation or validation program)
XVIII.
Document management operating procedures shall be established to systematically design, develop, review, approve
and issue documents. (Article 151) Document Management SOP
nineteen,
Documents should be drafted, revised, reviewed, approved, replaced or withdrawn, reproduced, stored and destroyed should be managed in accordance with the operating procedures, and there should be corresponding records of document distribution, withdrawal, reproduction and destruction. (Article 153) SOP for drafting, revising, reviewing, approving, replacing or withdrawing, copying, storing and destroying documents
Twenty,
Process procedures shall not be changed arbitrarily. If changes are needed, they should be revised, reviewed and approved in accordance with the relevant operating procedures. (Article 169)
SOP for process procedure revision, review and approval
XI.
Operating procedure for reproduction and distribution of original blank batch production records. (Article 173) Copying and issuing of original blank batch production records
SOP
xii.
Plant, equipment, materials, documents and records should be numbered (or coded), and develop operating procedures for the preparation of the number (or code), to ensure that the number (or code) is unique.
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