REQUIREMENTS FOR SANITARY REGISTRATIONS

IN GUATEMALA – PHARMACEUTICAL PRODUCTS

LEGAL DOCUMENTS: (DOCUMENTS REQUIRED IN ORIGINAL)

1. Certificate of free sale of the product (or CoPP type WHO) duly attested and with
their chain of legalizations.
2. Document which credits the legal representation granted by the manufacturer to
their distributor in Guatemala, for the latter may be authorized for performing the
procedures of registration, marketing and distribution of the products. In this case,
a list of the products involved must be included.
3. Certificate of Good manufacturing practices (GMP) duly attested and with their
chain of legalizations. In this case, if a third-party is involved on manufacturing or
packing, both GMP certificates are necessary.

TECHNICAL DOCUMENTS: (THEY CAN SEND VIA E-MAIL)

4. Quali quantitative Formula by dosage unit – i.e. capsule, tablet or the quantity of
liquid the patient must take: drop, five ml and etcetera. Also must include the FDA
or CI code of colors and flavors, if any-, (printed in the letterhead with stamp and
signature of the responsible)
5. Technical specifications of the finished product (printed in the letterhead with stamp
and signature of the responsible)
6. Method of analysis of finished product
7. Validation of the method / dissolution (applies in case of solid pharmaceutical
forms) * Please see the Annex A
8. Insert matter (if any)
9. Stability study - accelerated and in real time - (printed in the letterhead, including
the qualitative and quantitative formula, complete description of the packing
material and presentation, in three batches. The accelerated study with parameters
of 40°C + 2°C and RH 75% + 5%, for a minimum of six months. Real time
conditions: 30 °C + 2°C and RH 65% + 5% with conclusion of the studies. Include
the stamp and signature of the responsible)
10. Artworks of label and secondary packing
11. Standards of active principles (Minimum 200 mg each) packed in amber glass
bottle, the label must include the potency and storage conditions along with its
certificate of analysis.
12. Samples of the product (the quantity varies depending on the product and
presentation)

ANNEX A
Below you will find important remarks regarding to the Method of analysis and the
presentation of Validation Methods of Assay and Dissolution, for both Compendial and
Non Compendial Methods.

Important remarks on the method of analysis for the finished product:

Detail the procedure, sample preparation, standard preparation, concentration worked,

time and type of agitation (mechanical, sonication, and etcetera), type of analysis
(HPLC, UV-Visible Spectrophotometer, titration, IR analysis, and etcetera). The
conditions for the analysis must be very clear. Include a detailed procedure for
preparation of reagents and solutions to be used (mobile phase, dissolution media,
solvents, buffers, and etcetera)

Validation requirements (Analytical Method Validation – Assay Method - or

Dissolution Method):

1. Compendial Methods (USP/NF, BP, European Pharmacopoeia, Chinese

Pharmacopoeia, International Pharmacopoeia, Indian Pharmacopoeia):
IMPORTANT: In this case, a copy of the pharmacopoeia used must be included,
indicating the edition and year of the same.
a. Linearity: According to USP <1225> and ICH guidelines Q2 (R1), linearity
must be determined with five levels of concentration and three replicates per
level, in which the central point (100%) must be the concentration in which the
method of analysis (assay) is worked. In this parameter, it is required to present
the concentrations used in each level. In this case, only the system linearity
(worked with standard) must be presented.
b. Range: It is assessed according to the linearity.
c. Precision: According to USP <1225> and ICH guidelines Q2 (R1), precision
must be assessed through repeatability, reproducibility and/or intermediate
precision. A minimum of six (6) replicates at the 100% level is required. In this
case, only the precision worked with standard (system precision) must be
included.
IMPORTANT REMARKS:
- Each parameter must contain its statistical calculations, in which the
formulas, statistic treatment and criteria of acceptance are detailed.
Coefficient of variation, linear correlation along with its graphic, SR, RSD
and others.
- In the validation report, charts with the instrumental results of each
parameter must be included (absorbance, peak areas, ml –in titration- and
etcetera)
- Include a table with a summary indicating the following: Parameter
assessed, acceptance criteria and result obtained.
- Include the conclusions of each parameter assessed.
2. Non Compendial Methods (In – house methods):
a. Specificity: It is required to submit chromatograms or spectra of the sample,
standards, diluent, placebo and mobile phase (if applies). All those must be at
the same scale for an easy comparison.
b. Linearity: According to USP <1225> and ICH guidelines Q2 (R1), linearity
must be determined with five levels of concentration and three replicates per
level, in which the central point (100%) must be the concentration in which the
method of analysis (assay) is worked. In this parameter, it is required to present
the concentrations used in each level. In this case, the system linearity (worked
with standard) and the method linearity (worked with sample) must be
presented.
c. Range: It is assessed according to the linearity.
d. Accuracy: According to USP <1225> and ICH guidelines Q2 (R1), accuracy
must be determined based on three levels of concentration and three (3)
replicates in each level. In the event of using a matrix enriched or finished
product is mandatory to indicate the quantity (in mg) of active principle to use,
the amount recovered (in mg) and the percentage of recovery.
e. Precision: According to USP <1225> and ICH guidelines Q2 (R1), precision
must be assessed through repeatability, reproducibility and or intermediate
precision. A minimum of six (6) replicates at the 100% level is required. In this
case, both precisions (worked with standard and worked with sample) must be
included.
IMPORTANT REMARKS:
- Each parameter must contain its statistical calculations, in which the
formulas, statistic treatment and criteria of acceptance are detailed.
Coefficient of variation, linear correlation, SR, RSD and others.
- In the validation report, charts with the instrumental results of each
parameter must be included (absorbance, peak areas, ml –in titration- and
etcetera)
- Include a table with a summary indicating the following: Parameter
assessed acceptance criteria and result obtained.
- Include the conclusions of each parameter assessed.