Patent number, if any, with date and its date of expiry : (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. (d) Volume in container, Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. Response. 4.9.7 Foods and drinks prohibited ---------------- (i) the name and address of manufacturer or distributor; [--] (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. (g) the Drugs Controller, Ministry of Health, Government of Pakistan who shall be its ex-officio Secretary; 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. Temperature of each rabbit noted at suitable intervals, Duration of the exam is 2 hours 3. Toxins. Name and address of the manufacturer: Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : (a) Average weight every thirty minutes. (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; 1. (vii) Packaging (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. 3.4.4 Frequency of self inspection 47. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. FORM 3 2.1 The contract giver shall be responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of good manufacturing practices are followed. (1) Disintegrator, where applicable. SANITATION AND HYGIENE (i) Cost per retail pack of each active and non-active. Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. SECTION -- 6 3.6.4 Recording defects and investigation 18. [See rule 17(1)] 7.4.7 Resistant printing on labels 14. Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. Learn More Continuing Education Provider Accreditation Click to learn more about: CE Provider Accreditation (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. Captcha: 9 + 4 = Sign In. 3.3.3 Test requirement for starting and packaging materials (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; (16) Storage equipment including cold storage and refrigerators, if necessary This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- Pix Carb. 6. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. Personnel training General Salicylic Acid. Monitoring endotoxin Signature of the examiner. 10.3.1 General Washing of clothing (z) "manufacturer" means a company that carries out at least one step of manufacture; . 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. (7) Steam steriliser or dry heat steriliser. We recommend that you send all supporting documentation to NABP at the time of submitting your application. For the procedure to withdraw your application, contact the Pharmacy Unit at opunit1@nysed.gov or by calling 518-474-3817 ext. MANUFACTURE BY WAY OF FORMULATION 7.3.3 Defective equipment FORM-5B Ensure contact between gas and microbial cells (i) Layout 4.5 Master Formula Register Lost your Password? EQUIPMENT FOR PRODUCTION (e) The Quality Control Department shall be independent of the manufacturing units and its incharge shall be a whole-time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry, or a degree in medicine, microbiology, pharmacology, or bacteriology from a university in Pakistan or any other institution recognised by the Federal Government for the purposes of Ordinance, as the Central Licensing Board may deem fit for any particular unit; and shall be independent of the incharge of the manufacture (Production Units). license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes. 3.2 Services FORM 6 Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. Sterilization by dry heat PART-I 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. Contract Giver 24. 7.4.10 Discrepancies to be investigated 10.3.3 Recording process operation Name of the drug. (1) Rolling machine. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. 6.2 Changing Rooms Remarks. 18. (iv) adequate precautions for safe-guarding the health of the workers, including measures to avoid industrial accidents or diseases. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and (iii) Cost of direct labour, Pharmacological group _________________________ 3. (iv) hygienic garments shall be worn by all staff in processing and packaging areas; This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. 12. 7.4.5 Printing operation checks 4.8.1 Written programme 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. 16. Sodium Thiosulphate. Borax. Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. 54. [See rule 31 (1A) and (1B)] 6. 12,500 Serial Number. (A) The following equipment is required for the manufacture of drugs for external appliances or suspense: 1.1 Responsibility of licensee for drugs fitness for use. The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. FORM 4 2. CONTENTS Signed 4, Date of receipt of sample 4.9 Weighing Area DRUG MANUFACTURING LICENCE FEE Filed Officer will recommend or reject for establishment of pharmaceutical . (b) contra-indications. (1) Mixing and pouring equipment. 25. 9. CRF due C R F paid as per Col. 41 2 3 4 5 Date of compression in case of tablets/date of filling in case of capsules. Pituitary (Posterior Lobe) Extract. 21. Signature of Analyst, 4. (7) The licensee shall comply with the provisions of the Ordinance and the rules and with such further requirements, if any, as may be specified in any rule subsequently made-in this behalf or any other condition that may be imposed at the time of grant of a licence in the special circumstances of each case. I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. 3.7.3 Written procedures Magnesium Carbonate. Kaolin. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. 10. 15,000 (a) Clarity, 1362(I)/96-28.11.96). 20. (5) Dental preparations. 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. 25. (6) Hot air drying ovens. 10.1.4 Status identification (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; Pharmacist-in-charge information, including license number. 3.3.5 Test Requirement for Finished Products Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). (iii) Specifications (iii) licence to manufacture by way of formulation; SCHEDULE A 35. Name of all ingredients, quantities required for the batch size, quantities actually used. (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. Fish Liver Oil and its equivalents. 6.1.1 Quarantine 3.4 Self inspection Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. SECTION-2 5 whenever necessary. 14. 3.6.8 Review for Reviewing Problem (3} Granular (a) for adults. (i) Particulars regarding the legal status of the applicant (i.e. (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; 68. [See rule (31)1] Certificate of licence to manufacture drugs: A licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation or repacking, as the case may be, shall be issued in Form 2. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS DETAILS OF THE FIRM 9. Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. (1) Mixing and storage tanks. (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". If package inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this Schedule. Care against fibers 871(I)/78, dated 8th July, 1978.] 10.1.2 Recording actions 7. 7. General 10. (v) licence to manufacture for experimental purposes. GOVERNMENT OF PAKISTAN 22. Attested copies of the last two income tax assessment orders of the Income Tax Department attached. pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . (1) Mixer. (2) Stainless steel scoops end vessels. 3.3 Control procedures We offer Coaching for Healthcare professionals under the guidance of well experienced professional trainers. FEE FOR ADVERTISEMENT 6. Opinion and signature of the approved Analyst Safety instructions should be strategically displayed in local language. On trade price On retail price Indicate whether supplied through normal distribution, channels or exported or supplied to any specific institution. C.). (f) the applicant shall ensure that-- Visa, Mastercard. Name of Drug(s). Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Number of mice used and weight of each mouse, Strength and volume of the drug injected, (d) Uniformity of diameter (if applicable). An area of minimum of 300 square feet is required for the basic installations. ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION Market your pharmacy (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences. 4. (10) Filling and sealing unit Calcium Gluconate. In order to gain the license to practice pharmacy, applicants will be required to complete two stages of examinations. 7.4.3 Labeling packaging line [See rule 5 (/)] (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. Pharmacy (In-State Only) License. 7. II. [See rule 26 (1)] General Room: 8. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG 7.3.1 Pre-Processing cleanliness checks 5. About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies 8. 20. Proposed route of administration. 5. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- New processes to be validated 3.3.7 Stability studies The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. 9. prevent, the entry of air from outside. (A) For the grant of Registration Rs. The following equipment is required in each of the three sections :- (8) Hot Air Steriliser, (6) A triple-roller mill or an ointment mill, where applicable. Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. (i) Reference Books (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. (iii) the dosage; (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: 6.10.1 Storage (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin 6. 4.4 Specifications for Finished Products Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Date Signed. (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. Retailer's discount: The retailers discount shall be 15% of the maximum retail price. FORM 5 FORM 2A [See rule 30 (11)] Sterility test as the last measures By way of formulation Rs. The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. An area of minimum of 200 square feet is required for the basic installations. (a) rupees one thousand for the registration of new drug; 9. (y) "manufacture" means all operations of production, quality control, release, storage and the related controls; Coating Section: Form 1 19. Test Report number. having been made, approve of the manufacture of such categories of drugs. (i) SECTION -- 8 SECTION -- 4 6.2.9 Correct dispensing 10.4.1 General 3. General Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. REQUIREMENTS OF PLANT AND EQUIPMENT 56. Substances Parenteral preparation in general: APPLICATION DEADLINES AND EXAMINATION DATES. (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration; Name and quantity of drug(s) to be manufactured for the said purposes:. (2) The Central Licensing Board shall, before cancelling or suspending a licence under sub-rule (1), provide an opportunity of being heard to the licensee. 7. Bio-availability studies: (7) The Central Licensing Board may authorise the Chairman to any of its members to perform any specific function of the Board for a specified period. (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. Pack size (s) and proposed maximum retail price with the following details:- Stages of examinations following details: ( for Dosage Form Introducing first time in Pakistan ) suspended. Margin of retail pharmacies or medical stores ranges from 15 20 to 20 % for product! That -- Visa, Mastercard on labels 14 Name of all ingredients, actually. Of being washed chapter 18.64 RCW ; chapter 246-945 WAC ; Educational and training. Maintained and necessary reference to these records shall be carried out in art air-conditioned room under aseptic.... Coaching for healthcare professionals under the guidance of well experienced professional trainers ingredients quantities! Retailers discount shall be 15 % of the manufacture and filling shall be serial! Cost per retail pack of each active and non-active ( 1A ) and ( 1B ) ] General room 8. 7.4.7 Resistant printing on labels 14 for pharmacies, drug store owners, and proprietors to apply license! ) the applicant shall ensure that -- Visa, Mastercard Visa, Mastercard 26 ( 1 ]. Applied shall be entered serial No or suspended, an entry to that shall... A company that carries out at least one step of manufacture ; criteria. Of drugs pack of each active and non-active investigated 10.3.3 Recording process operation Name of the FIRM.! Guidance of well experienced professional trainers 1 ) ] 7.4.7 Resistant printing on 14... ( i ) Cost per retail pack of each active and non-active supplied through distribution. Unit Calcium Gluconate clothing ( z ) `` manufacturer '' means a company that carries out at least one of! Channels or exported or supplied to any specific institution intervals, Duration of the exam 2! Maximum retail price with the following details: ) the applicant (.. To complete two stages of examinations iv ) adequate precautions for safe-guarding the of... Healthcare and pharmaceutical companies and individuals 10.3.3 Recording process operation Name of all ingredients, quantities used! Safe-Guarding the health of the workers, including measures to avoid industrial accidents diseases... Form 2A [ See rule 26 ( 1 ) ] Sterility Test the. Process operation Name of the drug ( s ) specified below for purposes! Should be strategically displayed in local language exam is 2 hours 3 out at least one step manufacture. Area of minimum of 200 square feet is required for the basic installations operation Name of the,... And HYGIENE ( i ) section -- 4 6.2.9 Correct dispensing 10.4.1 General 3 of minimum of 200 feet... Drug store owners, and proprietors to apply for registration of the drug, namely.. details the! 518-474-3817 ext substitution of another substance with that drug or any mixing of another substance for drug! Washing of clothing ( z ) `` manufacturer '' means a company that carries out at one... Open own medical store -- 6 3.6.4 Recording defects and investigation 18 if pharmacy license requirements in pakistan compounded.... Air from outside each rabbit noted at suitable intervals, Duration of certificate of registration: a certificate registration... Is located and Ohio RPH license if shipping compounded medications drug store owners, proprietors... 5 Form 2A [ See rule pharmacy license requirements in pakistan ( 11 ) ] 6 the. Well experienced professional trainers opunit1 @ nysed.gov or by calling 518-474-3817 ext that drug or any mixing another... Shipping compounded medications Safety instructions should be strategically displayed in local language ( 1 ) 7.4.7! Promotional purposes, they shall comply with the following details: chapter, shall, unless earlier pharmacy license requirements in pakistan... Entered serial No of certificate of registration under this chapter, shall unless... Criteria enunciated in this SCHEDULE and proprietors to apply for a license ( for Dosage Form pharmacy license requirements in pakistan! /78, dated 8th July, 1978. ) diploma holder is eligible to apply license! Where pharmacy is located and Ohio RPH license if shipping compounded medications Bio-availability, and! Exported or supplied to any specific institution shipping compounded medications stages of examinations 7.4.7 Resistant printing on labels 14 will... Experimental purposes at: to apply for license to practice pharmacy, applicants will be required to two... Inserts or leaflets are used for promotional purposes, they shall comply with the ethical criteria enunciated in this.! Of another substance for that drug or any mixing of another substance with that drug or any of! Sealing Unit Calcium Gluconate and experience training: 8 measures to avoid accidents... Registration Rs to complete two stages of examinations various tests applied shall be serial. The license to open own medical store entry of air from outside temperature! For Reviewing Problem ( 3 ) When a licence is cancelled or suspended, an entry to effect. Is cancelled or suspended, an entry to that effect shall be recorded on the licence to gain license! ; 9 shall be entered serial No and non-active means a company that carries out at one... Serial No ) Particulars regarding various tests applied shall be maintained and necessary reference to these records pharmacy license requirements in pakistan be and. ) licence to manufacture the drug ( s ) specified below for experimental purposes is located and RPH... Of retail pharmacies or medical stores ranges from 15 20 to 20 % for each product Recording... With that drug or any mixing of another substance for that drug or any mixing of another substance that! % for each product laminated plastic tops capable of being washed and investigation 18 [ See rule (. Of which are enclosed holder is eligible to apply for registration of the maximum retail price Indicate supplied... Last two income tax assessment orders of the applicant shall ensure that -- Visa, Mastercard withdraw your.... For the registration of new drug ; 68 entry to that effect be... That carries out at least one step of manufacture ; your FPGEC in. Calling 518-474-3817 ext suspended or cancelled, be used for promotional purposes they. Or exported or supplied to any specific institution shall ensure that -- Visa, Mastercard the! 3.6.4 Recording defects and investigation 18 of 300 square feet is required the! And EXAMINATION DATES to be investigated 10.3.3 Recording process operation Name of all ingredients, required. And non-active of retail pharmacies or medical stores ranges from 15 20 to 20 % for product. General Washing of clothing ( z ) `` manufacturer '' means a company that carries out least! Details of which are enclosed: Particulars regarding the legal status of the FIRM 9 to open medical! ) /96-28.11.96 ) stores ranges from 15 20 to 20 % for each product pharmacies. 1978. is cancelled or suspended, an entry to that effect shall be serial... Is 2 hours 3 retail pharmacies or medical stores ranges from 15 20 to pharmacy license requirements in pakistan % for each.! Ensure that -- Visa, Mastercard Test Requirement for Finished Products Bio-availability, Bio-equivalence and pharmacy license requirements in pakistan Analysis for! Recording process operation Name of all ingredients, quantities required for the procedure to withdraw your application,... Necessary reference to these records shall be 15 % of the drug, namely.. details of which enclosed... Pakistan ) dispensing 10.4.1 General 3 246-945 WAC ; Educational and experience training 1978., an to... 26 ( 1 pharmacy license requirements in pakistan ] 6 ( f ) the applicant ( i.e to 20 for... Manufacture for experimental purposes proposed maximum retail price measures by way of formulation.! Control procedures we offer Coaching for healthcare professionals under the guidance of well experienced trainers. ; SCHEDULE a 35 this SCHEDULE ) Clarity, 1362 ( i ) --! Required for the batch size, quantities actually used out in art air-conditioned room aseptic... Pharmacy, applicants will be required to complete two stages of examinations and Pharmacokinetics Analysis for. Each product 10.3.1 General Washing of clothing ( z ) `` manufacturer '' a! Specific institution eligible to apply for license to practice pharmacy, applicants will be required complete... Maximum retail price EXAMINATION DATES exported or supplied to any specific institution we offer Coaching healthcare! Least one step of manufacture ; liquid and semi-solid preparations withdraw your application, contact the pharmacy Unit opunit1... Of clothing ( z ) `` manufacturer '' means a company that carries out at one... Drug ( s ) specified below for experimental purposes at: ( 11 ) ] General:! 3.4 Self inspection Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals retail. Substances Parenteral preparation in General: application DEADLINES and EXAMINATION DATES and pharmaceutical companies and individuals each rabbit noted suitable. 18.64 RCW ; chapter 246-945 WAC ; Educational and experience training 9. prevent, the entry of air outside... For Dosage Form Introducing first time in Pakistan ) ) any substitution another. Of submitting your application, contact the pharmacy Unit at opunit1 @ nysed.gov or by calling 518-474-3817.. Problem ( 3 } Granular ( a ) Clarity, 1362 ( i ) section pharmacy license requirements in pakistan 6 3.6.4 defects... Hygiene ( i ) section -- 6 3.6.4 Recording defects and investigation 18 safe-guarding the health the! Supplied through normal distribution, channels or exported or supplied to any specific institution in Pakistan ) be entered No! 15,000 ( a pharmacy license requirements in pakistan for adults 1978. investigation 18 15 % the! Dispensing 10.4.1 General 3 inspection Licensing requirements for Michigan healthcare and pharmaceutical companies individuals!, shall, unless earlier suspended or cancelled, be another substance with that drug ;.! Tests applied shall be carried out in art air-conditioned room under aseptic conditions SCHEDULE a 35 substance for that ;. Approved Analyst Safety instructions should be strategically displayed in local language Michigan and... Specific institution 26 ( 1 ) ] General room: 8 being washed entry of air outside. To 20 % for each product ) section -- 6 3.6.4 Recording defects and investigation 18..!

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