المادة 31 من تعليمات صناعة الأدوية والمستحضرات الحياتية والمبيدات البيطرية وتسجيلها وترخيصها وتداولها رقم 4 لسنة 2021

تلغي هذه التعليمات أية تعليمات سابقة . ملحق رقم (ا) GMP متطلبات GMP Check List Client is kindly requested to have the relevant documents available in the audit meeting room or assure easy access at the respective :documents storage place (Check if the master file is the same as the actual) Site Master File .1 List of products produced at the site .2 (reporting lines ,functions) Organization charts.3 Job descriptions.4 ”quality systems“ to address the ”Quality manual“ Is there.5 List of the key personnel and their qualifications especially the .6 Quality Assurance and microbiologist to see if ,QC ,Technical Director they are knowledgeable or not (names of the visitorsص فحة the 15 من 47if they record) Entrance .7 Personal .8 Does the company have an organization chart.a Does the company have a written job description .b Are the people in responsible position have adequate authority to .c carry out their responsibilities Does the company have adequate number of personal with the .d necessary qualification and practical experience Are the responsible persons meet the qualification requirements .e Documentation .9 Do specifications describe is detail the requirement with which the .a products or materials used or obtained during manufacture have to conform Does manufacturing formula processing and packaging.b instructions state all the starting materials use and lay down all processing and packaging operations ,Do procedures give directions for performing certain operations .c ,testing ,sampling ,environmental control ,clothing ,Cleaning .g.e equipment operation Do records provide a history of each batch of product including its .d distribution and also of all other relevant circumstances pertinent to the quality of the final product reviewed and distributed with ,prepared ,Do documents designed .e care Do documents comply with the related parts of the manufacturing.f and marketing authorization dossiers signed and dated by appropriate and ,Do documents approved.g authorized persons and purpose ,nature ,title ,Do documents have clear contents.h up to date-Do documents regularly reviewed and kept.i Are the documents printed and not handwritten and the entries .j legible and indelible handwritten ,made in clear Does any alteration made to the entry on a document signed and .k permit the reading of the original information where ,dated the reason for alteration , appropriate Are the records made or completed at the time each action is taken .l Are all significant activities concerning the manufacture of.m medicinal products are traceable Are the records retained for at least one year after the expiry date .n of the finished products Are only authorized persons be able to enter or modify date in the .o computer and there is a record of changes and deletions Does the access restricted by passwords or other means and the .p results of entry of critical data independently checked up-Does batch records electronically stored protected by back .q paper or other means and the ,microfilm ,transfer or magnetic tube date are readily available throughout the period of retention Documents Required .10 Are there appropriately authorized and dated specifications for .a where ,starting and packaging materials and finished products appropriate for intermediate or bulk products Is there an authorized manufacturing formula and processing.b instructions for each product and batch size to be manufactured s’which include all basic information required by GMP pack ,Are there authorized packaging instructions for each product.c P.M.required by G ,which include all basic information ,size and type are there recorded checks that the ,Before any processing begins.d ,equipment and work station are clear of previous products documents or materials not required for the planned process and .that equipment is clean and suitable for use Is there a batch packaging record kept for each batch or part batch.e processed Does the packaging record carry the batch number and the.f quantity of bulk product to be packed as well as the batch number and the planned quantity of finished product that will be obtained are there recorded checks ,Before any packaging operations begin.g that equipment and workstation are clear of previous products documents or materials not required for the planned packaging .operations and that equipment is clean and suitable for use Does the packaging record include all information that interned at .h the record is ,the time each action is taken and after completion responsible for the (s)dated and signed in agreement by person .packaging operaions Warehouses .11 (protocol) System for Good Storage Practice .a Weighing room.b Sampling room .c Check if sampling tools are available.d Check the cleanliness of sampling tools.e P for cleaning of sampling tools and weighing room.O.S .f Check the weighing checking and double checking.g (system and records) Receipt and storage of raw materials.h (locations and withdrawal) Computer control system .i Temperature mapping in warehouses .j Check how they select the locations of the thermometers.k Temperature and humidity records for the last two years in the .l s and finished products especially in summer’stores of API (list of products) Quarantine Area .m Check the storage conditions mentioned on the outer packs and .n compare the temperatures Pests traps .o Is if there is an adequate pest control program .p Check the availability of refrigerator for storage of certain products.q ?Ask for a list of such products stored in the refrigerator .r (separate area) Storage of labels .s Are the packaging materials separated in special area not .t accessible to every body Crowdedness of the store .u (QC or store keeper) Ask who stick the labels on containers .v Are storage areas of sufficient capacity to allow orderly storage of .w the various categories of materials and products Are storage areas designed or adapted to ensure good storage .x (temperature and humidity ,dry ,clean) c … [تتمة المادة في النص الرسمي]