Pharmaceutical Analysis Laboratory (PAL)

The PAL includes the following structural units

• Quality Assurance Department;
• Chemical Methods Department;
• Physico-Chemical Methods Department;
• Microbiological Methods and Antibiotic Activity Department;
• Virological and Immunobiological Research Department;
• Vivarium;
• Organizational Department;
• Logistics Department.

List of dosage forms of medicinal products assigned to the PAL

According to monographs on dosage forms of the current edition of the State Pharmacopoeia
of Ukraine

• vaginal preparations;
  • pessaries;
  • vaginal tablets;
  • vaginal capsules;
  • vaginal solutions, emulsions and suspensions;
  • tablets for vaginal solutions and suspensions;
  • soft vaginal preparations;
  • vaginal foams;
  • medicated vaginal tampons;
• ear preparations;
  • ear drops and sprays;
  • soft ear preparations;
  • ear powders;
  • ear washes;
  • ear tampons;
• granules;
  • effervescent granules;
  • coated granules;
  • modified-release granules;
  • gastro-resistant granules;
• capsules;
  • hard capsules;
  • soft capsules;
  • modified-release capsules;
  • gastro-resistant capsules;
  • cachets
• medicinal products for inhalation;
  • medicinal products intended for vapor generation
  • liquid medicinal products for spraying;
  • pressurized metered-dose inhalation medicinal products;
  • non-pressurized metered-dose inhalation medicinal products;
  • powders for inhalation;
• pressurized medicinal products;
• soft preparations for cutaneous use;
  • ointments;
  • creams;
  • gels;
  • pastes;
  • poultices;
  • medicated patches;
  • cutaneous patches;
• nasal medicinal products;
  • nasal drops and liquid nasal sprays;
  • nasal powders;
  • soft nasal medicinal products;
  • nasal washes;
  • nasal sticks;
• oromucosal preparations;
  • throat gargles;
  • mouthwashes;
  • gingival solutions;
  • oromucosal solutions and oromucosal suspensions;
  • soft oromucosal preparations;
  • oromucosal drops, oromucosal sprays and sublingual sprays;
  • lozenges and pastilles;
  • compressed lozenges;
  • sublingual and buccal tablets;
  • oromucosal capsules;
  • mucoadhesive preparations;
  • orodispersible films;
• eye preparations;
  • eye drops;
  • eye lotions;
  • powders for eye drops and lotions;
  • soft eye preparations;
  • ophthalmic inserts;
• sticks;
• parenteral preparations;
  • injections;
  • infusions;
  • concentrates for injection or infusion;
  • powders for injection or infusion;
  • gels for injection;
  • implants;
• medicated foams;
• transdermal patches;
• powders for cutaneous use;
• powders for oral use;
  • effervescent powders;
• irrigation preparations;
• rectal preparations;
  • suppositories;
  • rectal capsules;
  • rectal solutions, emulsions and suspensions;
  • powders and tablets for rectal solutions and suspensions;
  • soft rectal preparations;
  • rectal foams;
  • rectal tampons;
• liquid preparations for cutaneous use;
• liquid preparations for oral use;
  • oral solutions, emulsions and suspensions;
  • powders and granules for oral solutions and suspensions;
  • oral drops;
  • powders for oral drops;
  • syrups;
  • powders and granules for syrups;
• medicated tampons;

According to general monographs

• allergen products;
• vaccines for human use (list of monographs attached);
• dietary supplements;
• essential oils;
• animal immunosera for human use;
• cosmetic products;
• herbal raw material;
• herbal medicinal products;
• herbal blends;
• herbal teas;
• instant herbal teas;
• herbal raw material extracts;
  • liquid extracts;
  • tinctures;
  • soft extracts;
  • resins;
  • dry extracts;
• monoclonal antibodies for human use;
• products obtained using recombinant DNA technology;
• herbal fatty oils;
• substances for pharmaceutical use;
• biological medicinal products;
• homeopathic medicinal products;
• purified water, highly purified water, water for injections;
• intermediate products used for manufacturing medicinal products (including products in bulk);

Monographs on vaccines for human use

• BCG vaccine (lyophilized)
• BCG vaccine for immunotherapy
• Varicella vaccine (live)
• Hepatitis A vaccine (inactivated, virosomal)
• Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (adsorbed)
• Hepatitis A vaccine (inactivated, adsorbed)
• Hepatitis B vaccine (rDNA)
• Influenza vaccine (split virion, inactivated)
• Influenza vaccine (surface antigen, inactivated)
• Influenza vaccine (surface antigen, inactivated, virosomal)
• Influenza vaccine (whole virion, inactivated)
• Influenza vaccine (whole virion, inactivated, prepared in cell culture)
• Diphtheria vaccine (adsorbed)
• Diphtheria vaccine (adsorbed, reduced antigen content)
• Diphtheria and tetanus vaccine (adsorbed)
• Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content)
• Diphtheria, tetanus and pertussis (whole-cell) vaccine (adsorbed)
• Vaccine for the prevention of diphtheria, tetanus, and poliomyelitis (inactivated) (adsorbed, with reduced antigen content)
• Vaccine for the prevention of diphtheria, tetanus, and pertussis (acellular, component) and poliomyelitis (inactivated), (adsorbed)
• Vaccine for the prevention of diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and infections caused by Haemophilus Influenzae type b (conjugated), (adsorbed)
• Vaccine for the prevention of diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and infections caused by Haemophilus Influenzae type b (conjugated), (adsorbed)
• Vaccine for the prevention of diphtheria, tetanus, pertussis (whole-cell), poliomyelitis (inactivated) and infections caused by Haemophilus Influenzae type b (conjugated), (adsorbed)
• Vaccine for prevention of infections caused by Haemophilus Influenzae type b (conjugated)
• Yellow fever vaccine (live)
• Pertussis vaccine (acellular, component, adsorbed)
• Pertussis vaccine (acellular, total purified, adsorbed)
• Tick-borne encephalitis vaccine (inactivated)
• Measles vaccine (live)
• Measles, mumps and rubella vaccine (live)
• Measles, mumps, rubella and varicella vaccine (live)
• Rubella vaccine (live)
• Meningococcal group C vaccine (conjugated)
• Meningococcal vaccine (polysaccharide
• Human papillomavirus vaccine (rDNA)
• Mumps vaccine (live)
• Pneumococcal vaccine (polysaccharide)
• Pneumococcal vaccine (polysaccharide, conjugated, adsorbed)
• Poliomyelitis vaccine (inactivated)
• Poliomyelitis vaccine (oral)
• Tetanus vaccine (adsorbed)
• Rotavirus infection vaccine (live, oral)
• Rabies vaccine for human use (prepared in cell culture)
• Typhoid vaccine (polysaccharide)
• Cholera vaccine (inactivated, oral)

Monographs on immunosera for human use

• Botulinum antitoxin
• Antiserum against the venom of vipers common in Europe
• Gas gangrene antiserum (novji)
• Gas gangrene antiserum (perfringens)
• Gas gangrene antiserum (septicum)
• Gas gangrene antiserum, mixed
• Diphtheria antiserum
• Tetanus antiserum

Monographs on substances

• Low-molecular-weight heparins
• Interferon alfa-2 concentrated solution
• Interferon beta-1a concentrated solution
• Tuberculin purified protein derivative for human use

List of measurement (testing) methods that the PAL can perform

(A detailed list is given in the Laboratory's Scope of Attestation)

• Physical and physico-chemical methods;
• Identification;
• Limit tests for impurities;
• Assay methods;
• Biological tests;
• Biological assay methods;
• Pharmacognosy methods;
• Pharmaco-technological tests;
• Tests according to General monographs;
• Methods not described in the State Pharmacopoeia of Ukraine:
  • AND/QCM Identification and specific activity of probiotic preparations (determination of the number of live bacteria, antagonistic activity, acid formation) AND/QCM Identification and specific activity of bacteriophages

The PAL holds the following attestation/accreditation certificates for the above tests

The PAL is included in the list of WHO-prequalified medicines quality control laboratories

Participation of the PAL in laboratory proficiency testing programs

The Pharmaceutical Analysis Laboratory regularly participates in laboratory proficiency testing (PT) schemes to confirm the competence of the laboratory, which is one of the most important and mandatory elements of the quality assurance system for laboratories in accordance with ISO and GMP/GLP requirements.

Organizers of the PPT:

• KNMP PROFICIENCY PROGRAMME;
• World Health Organization;
• proficiency testing scheme (PTS) organized by the State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines" with the support of the State Service of Ukraine on Medicinal Products and Drugs Control;
• Interlaboratory comparison tests.