of May 28, 2015 No. 405
About approval of Rules of carrying out intra pharmaceutical control of the made medicines
According to article 68 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:
1. Approve the enclosed Rules of carrying out intra pharmaceutical control of the made medicines.
2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;
3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;
4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), and 3) of this Item.
3. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.
4. This order becomes effective after day of its first official publication.
Minister of health and social development of the Republic of Kazakhstan
T. Duysenova
Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of May 28, 2015 No. 405
1. These rules of carrying out intra pharmaceutical control of the made medicines (further - Rules) determine procedure for carrying out intra pharmaceutical control.
2. The head of drugstore appoints the pharmacist-analyst responsible for the organization and monitoring procedure of quality of the produced medicines in drugstore.
3. The head of drugstore provides workplace of the pharmacist-analyst with the standard set of measuring instruments, the test equipment, laboratory glassware, auxiliary materials applied when carrying out analytical works in drugstores according to the List of standard sets of measuring instruments, the test equipment, laboratory glassware, the auxiliary materials applied when carrying out analytical works in drugstore according to appendix 1 to these rules, and also regulatory legal acts of the Republic of Kazakhstan in the field of drug circulation, products of medical appointment and medical equipment, reference books.
4. The medicines made in drugstore including intra pharmaceutical procurement, the packed-up products, concentrates and semifinished products are exposed to intra pharmaceutical control.
5. Intra pharmaceutical control is carried out by carrying out:
1) preventive (precautionary) actions;
2) acceptance review of the initial materials (medicinal substance, excipient) used for production of medicines;
3) written control;
4) selective polling control;
5) organoleptic control;
6) selective physical control;
7) chemical control;
8) control in case of leave.
6. Results of organoleptic, selective physical control, chemical control of medicines are registered in the Magazine of registration of results of organoleptic, selective physical control, chemical control of intra pharmaceutical procurement, the medicines made according to recipes (requirements of the medical organizations), concentrates, semifinished products, trituration, ethyl alcohol and packing in form according to appendix 2 to these rules. Pages of the Magazine are numbered, stitched, certified by the signature of the head of drugstore and drugstores are sealed (in the presence).
7. Quality control of the medicine made in drugstore is carried out on compliance to indicators, methods and techniques according to Item 1 of article 66-1 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" in compliance.
8. Preventive (precautionary) actions consist:
1) in observance of conditions of aseptic production of medicines;
2) in ensuring operability and accuracy of weight measuring devices, carrying out their annual checking;
3) in providing proper conditions for obtaining, collection, storage of the water purified waters for injections, correctness of marking of reservoir in the form of specifying on label of the date of receipt, number of the analysis and signature of person making the analysis;
4) in adherence to deadlines, storage conditions of the reactants reference and the titrated solutions and their correct registration (on labels except the name, concentration, molarity, the date of receipt, end date of expiration date, the storage condition by whom it is made are specified);
5) in determination of variations in the checked medicines use of measuring means of the same type (with identical metrological characteristics), as in case of their production in drugstores;
6) in proper processing, filling, registration of byuretochny installation and shtanglas.
9. Shtanglasa (pharmaceutical container) draw up as follows:
1) on shtanglasa with medicinal substances and excipients which contain in rooms of storage also the manufacturing plant, number of series of the manufacturing plant, number effective period of the conclusion about safety and product quality, expiration date of medicinal substance, date of filling, the signature of the medicinal substance which filled штанглас and verified authenticity specify the name, the country;
2) on shtanglasa with medicinal substances and excipients which contain in the assistant room fillings of the shtanglas, the signature which filled штанглас and verified authenticity of medicinal substance and excipient specify date;
3) on shtanglasa with drugs, psychotropic substances, precursors, toxic agents is in addition specified by the highest one-time and daily doses;
4) on shtanglasa with the medicinal substances containing warm glycosides is specified by quantity of units of action in one gram of medicinal vegetable raw materials or in one milliliter of solution;
5) on shtanglasa with the medicinal substances intended for production of the medicines requiring aseptic conditions of production the text "For sterile medicines" is specified;
6) on shtanglasa with the medicinal substances containing moisture moisture percent, on cylinders with liquids (solution of hydrogen peroxide, ammonia solution, formaldehyde) specifies the actual content of active ingredient;
7) shtanglasa with solutions, tinctures and liquid semifinished products are provided with kaplemer or pipettes, with designation of quantity of the drops established by weighing in certain amount.
Information on filling of shtanglas and monitoring procedure on authenticity of the titrated solutions in byuretochny installation and shtanglasa with pipettes is registered registration of results of control of medicinal substances for authenticity in form according to appendix 3 to these rules. Pages of the Magazine are numbered, stitched, certified by the signature of the head of drugstore and drugstores are sealed (in the presence).
Filling of shtanglas and the burette in byuretochny installation it is carried out only after complete use of the substances which are in them and their processing.
10. Acceptance review of the initial materials (medicinal substance, excipient) used for production of medicines consists in verification of documentation characterizing lot of products (commodity transport delivery note, the quality certificate of the manufacturing plant), compliance of series on samples of medicinal substances and excipients to the series specified in the accompanying documentation, observance of storage conditions, transportation, and also identification of medicinal substances and auxiliary materials on indicators "Packaging", "Marking" and "Description".
On indicator "Packaging" is checked integrity and compliance to physical and chemical properties of medicinal substances and excipients.
On indicator "Marking" is checked availability on the label of the manufacturing name or the company making final packing, the name of medicinal substance, excipient, its weight (I will eat around), with indication of their quantity, structure per unit mass or amount, number of series, expiration date, date of packing.
On indicator "Description" is checked appearance, color, smell, uniformity, lack of visible mechanical inclusions in solutions.
11. In case of doubt in quality on one of the indicators specified in Item 10 of these rules, samples of medicinal substances and excipients go to the expert organization.
Before receipt of analysis results, rejected initial materials are marked and stored in drugstore is isolated from other initial materials.
12. In case of establishment of discrepancy when carrying out acceptance review on indicators "Packaging", "Marking", "Description", initial materials return to the supplier or are destroyed.
13. All are exposed to written control, without exception, the medicines made in drugstore.
14. Written control consists in filling of control leaf of any form right after medicine production.
In control leaf it is specified:
1) date of production;
2) number of the recipe or the requirement of the medical organization with indication of the name of department;
3) names of the taken medicinal substances, their quantity, total amount or weight, number of doses;
4) signatures made, packed up and checked medicine.
In control leaf of the name of drugs, toxic, psychotropic substances, precursors are emphasized with red pencil, on medicines for children the letter "D" is put. The control leaf is filled in Latin according to the sequence of manufacturing techniques. When filling control leaf names of consistently taken homeopathic ingredients are specified homeopathic medicines.
In case of use of semifinished products and concentrates in control leaf their structure, concentration, the taken amount or weight are specified. In case of production of powders, suppositories and pills the lump, quantity and mass of separate doses is specified. Lump of pills or suppositories, concentration and amount (or weight) the isotinting and stabilizing substances added to eye drops, solutions for injections and infusions is specified as well on recipes.
All calculations are made before production of medicine and register on reverse side of control leaf.
In control leaf formulas of calculation and water absorption coefficients used at the same time for medicinal vegetable raw materials, coefficients of increase in amount of solutions are specified in case of dissolution of medicinal substances, substitution coefficients in case of production of suppositories.
15. On the medicines made and released by the same person, control leaf it is filled in the course of medicine production.
16. Control leaves remain in drugstore within one month from the date of medicine production.
17. The made medicines, recipes and the filled control leaves are transferred to check to the pharmacist-technologist performing control functions on observance of manufacturing techniques and leave of medicines. Check consists in establishment of compliance of entries in control leaf of copy-book in the recipe, correctness of the made calculations.
Following the results of check of complete chemical quality control of medicine, in control leaf number of the analysis and the signature of the pharmacist-analyst is put down.
18. Selective polling control is carried out after production by the druggist no more than five medicines.
When carrying out selective polling control the pharmacist-technologist calls the first substance entering medicine, and in medicines of complex structure specifies also its quantity then person who carried out its production calls all taken medicinal substances and their quantity. When using semifinished products (concentrates) the druggist calls also their structure and concentration.
19. If during polling control it is determined that the mistake in medicine production is made, then it is subject to physical and chemical control. In case of impossibility of carrying out physical and chemical control medicine is liable to destruction according to Rules of destruction of the medicines, products of medical appointment and medical equipment which became useless, counterfeited, expired, approved by the order of the Minister of health and social development of the Republic of Kazakhstan of August 26, 2015 No. 687 (registered in the Register of state registration of regulatory legal acts No. 12122).
20. Organoleptic control consists in medicine check, including homeopathic, on indicators appearance, color, smell, uniformity, lack of visible mechanical inclusions in solutions.
Medicines for the internal use are checked for taste for adults - selectively, for children - it is obligatory.
21. Uniformity of powders, homeopathic trituration, ointments, pills, suppositories is checked before separation of homogeneous mass into doses according to requirements of GF RK.
During the working day at each druggist check of different types of medicines is selectively performed.
22. Selective physical control consists in check of lump or amount of medicine, quantity and mass of the separate doses entering this medicine (but at least three doses), and quality of packing.
Are exposed to selective physical control:
1) each series of packing of industrial output and intra pharmaceutical procurement in number of three-five packagings, including packing of homeopathic medicines regarding observance of regulation of variations, admissible in case of production of medicines (including homeopathic) in drugstore and regulations of variations, admissible when packing industrial output;
2) at least three percent of the medicines made according to recipes (requirements) in one working day;
3) quantity of homeopathic granules in certain mass of hinge plate;
4) each series of the medicines which are requiring sterilization, after packing before their sterilization in number of at least five bottles (bottles) on mechanical inclusions (mobile insoluble substances, except gas bubbles, accidentally present at solutions).
23. In the course of production solutions are exposed to primary and secondary control on mechanical inclusions:
1) primary control is exercised after filtering and packing of solution. At the same time each bottle or bottle with solution is looked through. In case of detection of mechanical inclusions solution is repeatedly filtered, corked, again looked through, marked and sterilized. The solutions made in aseptic conditions look through once after pouring or the sterilizing filtering;
2) all bottles and bottles with solutions which passed sterilization stage before registration and packaging are subject to secondary control.
24. For viewing of bottles (bottles) in prescription production department of drugstore the special workplace protected from hit of direct sunshine where the "Device for Control of Solutions on Lack of Mechanical Pollution" device is established is created. The black-and-white screen lit is used so that to exclude hit of light in eyes it is direct from its source.
25. Control is exercised by the pharmacist-technologist by viewing of solutions with the naked eye on the black and white backgrounds lit with electric opaque lamp in sixty watts or fluorescent lamp in twenty watts for the painted solutions on black background – hundred watts, on white - thirty watts. Distance from eye to the looked-through object twenty five - thirty centimeters, and corner of optical axis of viewing to the direction of light about ninety degrees. The line of sight goes to bottom in case of vertical position of the head.
26. The looked-through bottles and bottles have net and dry outside surface.
27. Depending on amount of bottle or bottle look through at the same time from one to five pieces. Bottles or bottles take in one or in both hands for mouths, bring in control zone, smooth movement overturn in the provision "up is bottom" and look through on black and white backgrounds. Then smooth movement, without stirring, overturn in the initial provision "down is bottom" and also look through on black and white backgrounds.
28. Control time, without costs for auxillary operations, constitutes:
1) one bottle (bottle) with a capacity of hundred - five hundred milliliters up to twenty seconds;
2) two bottles (bottles) with a capacity of fifty - hundred milliliters ten seconds;
3) from two to five bottles (bottles) with a capacity of fifty milliliters within eight - ten seconds.
29. The bottles or bottles rejected on availability of mechanical inclusions choose and stack separately in special container. They are revealed and merge content.
30. Chemical control consists in quality evaluation of production of medicines on indicators:
1) authenticity, testing for purity and admissible limits of impurity (qualitative analysis);
2) quantitative determination (quantitative analysis) of the medicinal substances which are its part.
31. Are exposed to qualitative analysis:
1) the water purified, water for injections daily (from each cylinder, and in case of water supply on the pipeline on each workplace) on lack of chlorides, sulfates and salts of calcium.
The water for injections intended for the medicines requiring aseptic conditions of production except the testing stated above needs to be checked for lack of the recovering substances, salts of ammonium and carbonic anhydride according to requirements of GF RK.
Results of qualitative analysis are registered in the Magazine of registration of results of control of the water purified and waters for injections in form according to appendix 4 to these rules which pages are numbered, stitched, certified by the signature of the head of drugstore and drugstores are sealed;
2) all medicines, concentrates and semifinished products (including homeopathic tinctures, trituration, solutions, cultivations) arriving from placements of storage to the assistant room, and in case of doubt - the medicinal substances arriving in drugstore from warehouse of the supplier;
3) concentrates, semifinished products and liquid medicinal substances in byuretochny installation and in shtanglasa with pipettes in the assistant room when filling;
4) the medicines of industrial production which are packed up in drugstore, the intra pharmaceutical procurement made and which is packed up in drugstore (each series).
32. Are exposed to qualitative analysis selectively:
1) the medicines made according to recipes and requirements of the medical organizations. At each druggist during the working day at least ten percent from total quantity of the made medicines are checked;
2) medicines for children, the medicines applied in eye practice, containing the drugs, psychotropic substances, precursors, toxic agents, homeopathic remedies before the fourth decimal cultivation containing poisonous, inorganic and organic.
33. Results of qualitative analysis are registered in the Magazine of registration of results of control of medicinal substances for authenticity.
34. Are exposed to complete chemical control (qualitative and quantitative analysis):
1) solutions for injections and infusions before sterilization, including determination of size of acid-base balance (рН), the isotinting and stabilizing substances.
For control after sterilization one bottle from each series is selected and checked for the size of acid-base balance, authenticity and quantitative content of active ingredients;
2) sterile solutions for outside application (ophthalmologic solutions for irrigations, solutions for treatment of burn surfaces and open wounds, for intravaginalny introduction and others);
3) eye drops and ointments, content of the isotinting and stabilizing substances in which it is determined before sterilization;
4) medicines for newborn children (in the absence of techniques of quantitative analysis, these medicines are exposed to qualitative analysis).
Production of medicines, complex on structure, for the newborn children who do not have techniques of qualitative and quantitative analysis is made under observation of the pharmacist-analyst;
5) solutions of atropine of sulfate and acid chlorohydrogen (for the internal use), solutions of mercury of dichloride and silver of nitrate;
6) concentrates, semifinished products, trituration, including liquid homeopathic cultivations of inorganic and organic medicinal substances and their trituration before the third decimal cultivation. Production of the homeopathic medicines which do not have techniques of qualitative and quantitative analysis is made under observation of the pharmacist-analyst;
7) intra pharmaceutical procurement of medicines (each series);
8) the stabilizers used in case of production of solutions to injections and the buffer solutions applied in case of production of eye drops;
9) concentration of ethyl alcohol by determination of density (alcoholometer) in case of cultivation in drugstore, and in case of need - in case of acceptance from warehouse of the supplier;
10) concentration of ethyl alcohol in aqueous-alcoholic homeopathic solutions, cultivations and drops (each series);
11) homeopathic granules on disintegration (each series).
35. The medicines made in drugstore according to recipes or requirements of the medical organizations in number of at least three medicines in one change selectively are exposed to complete chemical control (qualitative and quantitative analysis).
The medicines for children applied in eye practice, containing drugs, psychotropic substances, precursors and toxic agents and also solutions for medical enemas require special attention.
36. The complete chemical analysis of the purified water is quarterly carried out.
37. Production of fragrant waters, intra pharmaceutical procurement of medicines for the outside application, medicines containing tar, Ichthyolum, sulfur, the Naftalan oil, collodion, lead water, and also homeopathic medicines which analysis it is not possible to perform in the conditions of drugstore is carried out at presence (under control) the pharmacist-analyst.
38. All medicines made in drugstores, including homeopathic are exposed to control in case of leave.
Control in case of leave includes check of compliance:
1) packagings of medicines to physical and chemical properties of the medicinal substances entering them;
2) the doses specified in the recipe, including the highest one-time doses, the highest daily doses of medicines to age of the patient;
3) numbers on the recipe and numbers on the label;
4) surnames of the patient on the receipt, surname on the label and the recipe;
5) registrations of medicines to the requirements established by the legislation of the Republic of Kazakhstan in the field of drug circulation, products of medical appointment and medical equipment.
39. The medicines released in the medical organizations are drawn up by texts on solutions for medical enemas – "For enemas", on solutions for disinfection - "For disinfection", "Handle care", on all medicines released in children's departments – "Children's".
40. Person exercising control in case of medicine leave is signed on reverse side of the recipe (requirement).
41. For implementation of control and analytical servicing, control of quality of the made dosage forms in the conditions of drugstore, the drugstore concludes providing with the chemical reactants titrated by solutions according to the Civil code of the Republic of Kazakhstan of December 27, 1994 (further - the Civil code) with the republican state company on the right of economic maintaining "The national center of examination of medicines, products of medical appointment and medical equipment" of the Ministry of Health of the Republic of Kazakhstan (further – the Center) which is the state expert organization in the field of drug circulation, products of medical appointment and medical equipment or with its territorial branches the agreement on control and analytical servicing and providing with the chemical reactants titrated by solutions (further - the agreement).
The center and its territorial branches have the test laboratories (further – test laboratory) accredited according to the Rules of carrying out accreditation of the test laboratories performing exclusive activities for examination and estimates of safety and quality of medicines, products of medical appointment, approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 412 (registered in the Register of state registration of regulatory legal acts No. 11487).
The choice of test laboratory is performed at the discretion of drugstore.
Acquisition by drugstore of chemical reactants and the titrated solutions is made based on the requirement of chemical reactants and the titrated solutions for form provided to test laboratory according to appendix 5 to these rules.
Payment of cost of control and analytical servicing, control of quality of the made dosage forms in the conditions of drugstore and providing with the chemical reactants titrated by solutions is made by drugstore based on the agreement, concluded according to the Civil code.
42. The list of concentrates, semifinished products and intra pharmaceutical procurement of the medicines produced in drugstore affirms test laboratory with which the agreement on control and analytical servicing according to the Rules of production of medicines and products of medical appointment approved by the order of the Government of the Republic of Kazakhstan of January 16, 2012 No. 60 is signed. The dosage forms containing compatible medicines on which there are analysis techniques for complete chemical control with fixed terms of the validity are included in this list.
43. The test laboratory performs departure in drugstore once a quarter subjects to selective complete physical and chemical control one percent from the made types of medicines, available in day of visit, but at least five medicines, including the water purified, water for injections, medicines for newborns, the children's medicines intended to children till 1 year, sterile and unsterile medicines, unstable and perishable medicines (solutions of ammonia, hydrogen peroxide, iodine and formaldehyde) and intra pharmaceutical procurement.
The analysis of the made medicines is carried out by specialists of test laboratory directly in drugstore. In case of impossibility to exercise quality control of dosage form in the conditions of drugstore, such medicines are subject to withdrawal, at the same time the statement of withdrawal of the medicines taken for control of their quality by test laboratory of the expert organization (territorial branch) in form according to appendix 6 to these rules is drawn up.
44. Results of visit of drugstore and the carried-out analyses of quality control of the made medicines are registered visits of drugstore by specialists of test laboratory of the expert organization for form according to appendix 7 to these rules. Pages of the magazine are numbered, laced up and certified by the signature of the head and seal of the pharmaceutical organization (in the presence) and is vised by test laboratory.
to Rules of carrying out intra pharmaceutical control of the made medicines
The list of standard sets of measuring instruments, the test equipment, laboratory glassware, the auxiliary materials applied when carrying out analytical works in drugstores
1. Standard set of measuring instruments, test equipment
1. Scales ravnoplechy weighings, manual with limits, in grams: from 0,02 of grams to 1 gram; from 0,1 of grams to 5 grams; from 1 gram to 20 grams; from 5 grams to 100 grams.
2. Scales technical pharmaceutical VA-4.
3. Weights technical the fourth class from 10 mg to 1 kg.
4. Weights technical second class milligram (weight).
5. rn-meter (or ionomer).
6. Refractometer.
7. The thermometer mercury glass laboratory in 1 ° C from 0 ° C to 100 ° C.
8. The thermometer technical for drying cabinet from 0 ° C to 200 ° C.
9. Areometers (or densimetra).
10. Alcoholometers glass (set).
11. The device for control of sterile solutions on lack of mechanical inclusions (UK-2).
12. Bath water laboratory with fire or electric heating. 13. Rangette laboratory.
14. Spirit-lamp.
15. The magnifying glass is manual tenfold.
16. Electric drying cabinet.
17. Desktop hourglasses on 1, 2, 3, 5 minutes or the alarm watch. 18. Indicators and reactants.
2. Approximate list of laboratory glassware, auxiliary materials
1. The burette direct with the crane (or with olive) capacity: 10 milliliters, 25 milliliters (further – ml).
2. Funnel dividing cylindrical capacity: 50 ml; 100 ml.
3. Board glass or porcelain for the drop analysis.
4. Funnel simple cone-shaped with short stalk No. 1 D 25 of mm; Mm N 2 D 35.
5. Dropper for indicators and reactants.
6. Beakers glass capacity: 50 ml (price of division of 5 ml); 100 ml (price of division of 10 ml); 500 ml (price of division of 25 ml).
7. Microburettes capacity: 3 ml (price of division of 0,02 of ml); 5 ml (price of division of 0,02 of ml).
8. Sticks glass, D 3 mm.
9. Pipette pharmaceutical with by-pass tube capacity: 3 ml; 6 ml.
10. Pipette eye.
11. Pipette (Mora) with one tag, capacity: 5 ml; 10 ml; 20 ml; 25 ml.
12. Pipette with divisions, capacity: 1 ml (price of division of 0,01 of ml); 2 ml (price of division of 0,02 of ml); 5 ml (price of division of 0,05 of ml); 10 ml (price of division of 0,1 of ml).
13. Test tubes chemical with diameters of 14 mm; 16 mm; 21 mm.
14. The test tubes graduated capacity: 5 ml; 10 ml; 15 ml; 20 ml.
15. Glasses high and low of heat-resistant glass, capacity: 50 ml; 100 ml; 250 ml; 400 ml.
16. Glasses subject with deepenings (for the drop analysis).
17. The mortar and pestle 3rd diameter are 86 mm.
18. Tubes calcium chloride with one sphere: diameter is 25 mm; diameter is 30 mm.
19. Cylinders measuring with nose capacity: 5 ml; 10 ml; 25 ml; 50 ml; 100 ml; 250 ml; 500 ml.
20. Cylinders measuring with prishlifovanny stopper capacity: 10 ml; 25 ml; 50 ml; 100 ml; 250 ml; 500 ml.
21. Cup vyparitelny porcelain No. 1-3, capacity: 25 ml; 50 ml; 100 ml.
22. Bank with the ground-in stopper, with a capacity of 25 ml; 50 ml; 100 ml.
23. Petri's cup of D-100 of mm.
24. Filter paper.
25. Pear rubber for microburettes and pipettes.
26. Clips for rubber tubes (screw Hoffman or the springing Mora).
27. Kapsulatorka from plastic 1 (small), 2 (average), 3 (big).
28. Pencil on glass, stick graphite (make of solid graphite, simple pencil which before the use is calcinated).
29. Scissors, tweezers.
30. Support polyethylene on 10 test tubes, 20 test tubes.
31. The pallet from polymeric materials or porcelain.
to Rules of carrying out intra pharmaceutical control of the made medicines
The magazine of registration of results of organoleptic, selective physical control, chemical control of intra pharmaceutical procurement, the medicines made according to recipes (requirements of the medical organizations), concentrates, semifinished products, trituration, ethyl alcohol and packing
|
Date of control |
No. of payment order (number of the analysis) |
No. of the recipe or the requirement of the medical organization with indication of department |
No. of series of intra pharmaceutical procurement (for packing it is specified to No. of series or No. of the analysis of manufacturer or test laboratory) |
Composition of medicine or the determined substance (ion). Symbol for medicines of individual production (for children - "Д"; in eye practice of "Hl"; Content of drugs, psychotropic, toxic agents and precursors is emphasized with red pencil) |
Results of selective physical, organoleptic control (organoleptic control is considered as check by physical control) |
|
1 |
2 |
3 |
4 |
5 |
6 |
continuation of the table
|
Results of high-quality control (authenticity determination) "+" or "-" |
Results of complete chemical control (calculation formula, density, index of refraction, etc.) |
Surname made, packed up |
Signature of checked |
Quality evaluation | |
|
well |
Not well (it is emphasized | ||||
|
7 |
8 |
9 |
10 |
11 |
12 |
to Rules of carrying out intra pharmaceutical control of the made medicines
Magazine of registration of results of control of medicinal substances for authenticity
|
Date of filling and control |
No. of payment order (it is analysis No.) |
Name |
No. of series of medicinal substances or No. of the analysis of test laboratory |
No. of the las filled bars |
The determined substance (ion) |
Quality evaluation of medicinal substances ("corresponds", does not correspond") |
Signature of filled |
Signature of checked |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
to Rules of carrying out intra pharmaceutical control of the made medicines
The magazine of registration of results of control of the water purified and waters for injections
|
The date of receipt (water otgonka) |
Date of control |
No. of payment order ( it is analysis No.) |
cylinder No. |
Results of control on lack of impurity: | ||
|
Chloride |
Sulfate |
Calcium salts | ||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
continuation of the table
|
Results of control on lack of impurity: (lack of impurity is noted by sign "-") |
Quality evaluation of the water purified and waters for injections |
Signature of checked | |||
|
Ammonium salts |
The recovering substances |
Dioxide carbon |
well |
Not well | |
|
8 |
9 |
10 |
11 |
12 |
13 |
to Rules of carrying out intra pharmaceutical control of the made medicines
Form
The requirement of chemical reactants and the titrated No. solutions ______
from "____" ___________ 20 ____.
Name of the pharmaceutical organization __________________________
According to the contract for control and analytical servicing
No. _______ from _____________________________
The following reactants and the titrated solutions are necessary for carrying out intra pharmaceutical control of the made medicines:
the following reactants and the titrated solutions are necessary:
|
№ of payment order |
The name of reactant / the titrated solution |
Measurement unit. |
Quantity of requested |
Quantity of released |
|
1 |
2 |
3 |
4 |
5 |
_____________________________________ __________
Surname, name, middle name (in case of its availability), the signature
head of the pharmaceutical organization
L. S. (in the presence)
to Rules of carrying out intra pharmaceutical control of the made medicines
Form
The act of withdrawal of the medicines taken for control of their quality by test laboratory of the expert organization (territorial branch)
________________________________________________________________________________
(the name of test laboratory of the expert organization (territorial branch) from drugstore
________________________________________________________________________________
(name of drugstore)
from "__" _________ 20 __.
Surname, name, middle name (in case of its availability) the specialist who withdrew medicines on the analysis
______________________________________________________________________________
At presence ___________________________________________________________________
(Surname, name, middle name (in case of its availability) the specialist of drugstore)
|
№ of payment order |
No. of the recipe (requirement) |
Composition of medicine |
Surname, name, middle name (in case of its availability) |
Medicine cost |
Medicine quality evaluation | |||
|
The made person |
The packed-up person |
The checked person |
well |
not well | ||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
____________________________________ __________________
Surname, name, middle name (in case of its availability), (signature)
position of the specialist test
laboratories of the expert organization
(territorial branch)
____________________________________ ___________________
Surname, name, middle name (in case of its availability), (signature)
head of drugstore
to Rules of carrying out intra pharmaceutical control of the made medicines
Form
Magazine of visits of drugstore by specialists of test laboratory of the expert organization
|
It is carried out testing in drugstore |
| ||||
|
№ of payment order |
Date |
Actions of test laboratory |
No. of the recipe (requirement) |
Composition of medicine |
|
|
1 |
2 |
3 |
4 |
5 |
|
|
Quality control of medicines | ||||||
|
Results of control |
Quality evaluation |
Date of accounting of the medicines taken for control of their quality |
Surname Name Middle name | |||
|
High-quality |
Quantitative |
Well |
Unsatisfactorily |
Specialist of test laboratory |
Head of drugstore | |
|
6 |
7 |
8 |
9 |
10 |
11 |
12 |
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The document ceased to be valid since January 5, 2021 according to Item 2 of the Order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-287/2020