Non-sterile Pharmaceutical Products Research Articles

A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products

In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia cepacia complex (BCC), Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Clostridium sporogenes, Candida albicans, and Mycoplasma spp., some of which may be missed or not identified by traditional culture-dependent methods. In this study, we employed a metagenomic approach to detect these taxa, avoiding the limitations of conventional cultivation methods. We assessed the groundwater microbiome’s taxonomic and functional features from samples collected at two locations in the spring and summer. All datasets comprised 436–557 genera with Proteobacteria, Bacteroidota, Firmicutes, Actinobacteria, and Cyanobacteria accounting for > 95% of microbial DNA sequences. The aforementioned species constituted less than 18.3% of relative abundance. Escherichia and Salmonella were mainly detected in Hot Springs, relative to Jefferson, while Clostridium and Pseudomonas were mainly found in Jefferson relative to Hot Springs. Multidrug resistance efflux pumps and BlaR1 family regulatory sensor-transducer disambiguation dominated in Hot Springs and in Jefferson. These initial results provide insight into the detection of specified microorganisms and could constitute a framework for the establishment of comprehensive metagenomic analysis for the microbiological evaluation of pharmaceutical-grade water and other non-sterile pharmaceutical products, ensuring public safety.

Storage implications on the microbiological quality of some locally manufactured pharmaceuticals

Pharmaceutical products non-sterile are expected to have a minimal microbial load which must not exceed the limits as stated in pharmacopoeia monographs. This study attempted to evaluate storage implications on the microbiological quality of some non-sterile pharmaceutical products manufactured locally in some states in south east Nigeria. Twenty brands of pharmaceutical products comprising 13 tablets, 5 capsules and 2 suspension procured from patent medicine and local drug markets in Aba and Enugu states were stored at room temperature (25oC) for 6 months. Microbial growth was evaluated at 0 and 6 months using standard microbiological procedures including Total aerobic bacteria plate count, isolation, characterization and identification of microbial contaminants. The results from the study showed that 55% and 30% of the pharmaceutical products had bacteria and fungi contamination at 0 month which increased to 70% and 50% at 6 months storage period respectively. Statistical analysis showed there was a significant increase (p < 0.05) in growth of micro-organisms at 6 months for both bacteria and the fungi/moulds (p < 0.05). The isolated bacteria were Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli while the fungi include Trichosporonasahii, Curvularia bothriochloae, Candida albicans, Candida parapsilosis. All contaminated samples had microbial counts above the British Pharmacopoeia (BP) acceptabl limit of 103 and 102 CFU/ml for bacteria and fungi respectively. This can be attributed to poor adherence to current Good Manufacturing Practice (cGMP) by the manufacturers. Thus, it is recommended that manufacturers adhere strictly to cGMP and storage conditions stated on these pharmaceutical products followed strictly during distribution and storage to reduce the levels of microbial contamination.

Microbiological Quality of Selected Non-Sterile Pharmaceutical Products Retailed in Anyigba, Kogi State, Nigeria

This study was designed to check for the microbiological quality of non-sterile products retailed in Anyigba. The use of contaminated non-sterile pharmaceutical products can cause hazards in a majority of ways like economic loss to the industrialists, alter the therapeutic effect of the drug and affect the health of a patient. A total of 10 samples were collected; the isolated organisms were characterized and identified by using morphological, cultural and biochemical tests. The organisms isolated were Staphylococcus aureus, E.coli and Pseudomonas spp, Aspergillus spp, Mucorspp, Saccharomyces spp and Rhizopus spp. The percentage of the isolate includes S. aureus 37 (45.7%), E.coli 16 (19.7%) Pseudomonas spp 28 (34.5%) to safeguard the product from contamination, it is important to ensure that good manufacturing practices such as raw material testing, equipment sanitization and automation, microbial testing of water, training of personnel, post marking surveillance, monitoring of environment among others were employed. The focus should also be on surveillance and effective monitoring of the distribution and marketing of pharmaceutical products. Local regulatory agencies such as the Standard Organization of Nigeria (SON), and the National Agency for Food,drug administration and Control (NAFDAC) should always ensure that all pharmaceuticals released into the market for sales and consumption should conform to specifications and are fit for their intended use.

Microbiological Quality of Selected Non-Sterile Pharmaceutical Products Retailed in Anyigba, Kogi State, Nigeria

This study was designed to check for the microbiological quality of non-sterile products retailed in Anyigba. The use of contaminated non-sterile pharmaceutical products can cause hazards in a majority of ways like economic loss to the industrialists, alter the therapeutic effect of the drug and affect the health of a patient. A total of 10 samples were collected; the isolated organisms were characterized and identified by using morphological, cultural and biochemical tests. The organisms isolated were Staphylococcus aureus, E.coli and Pseudomonas spp, Aspergillus spp, Mucorspp, Saccharomyces spp and Rhizopus spp. The percentage of the isolate includes S. aureus 37 (45.7%), E.coli 16 (19.7%) Pseudomonas spp 28 (34.5%) to safeguard the product from contamination, it is important to ensure that good manufacturing practices such as raw material testing, equipment sanitization and automation, microbial testing of water, training of personnel, post marking surveillance, monitoring of environment among others were employed. The focus should also be on surveillance and effective monitoring of the distribution and marketing of pharmaceutical products. Local regulatory agencies such as the Standard Organization of Nigeria (SON), and the National Agency for Food,drug administration and Control (NAFDAC) should always ensure that all pharmaceuticals released into the market for sales and consumption should conform to specifications and are fit for their intended use.

Propidium Monoazide (PMAxx)-Recombinase Polymerase Amplification Exo (RPA Exo) Assay for Rapid Detection of Burkholderia cepacia Complex in Chlorhexidine Gluconate (CHX) and Benzalkonium Chloride (BZK) Solutions.

Both sterile and non-sterile pharmaceutical products, which include antiseptics, have been recalled due to Burkholderia cepacia complex (BCC) contamination. Therefore, minimizing the frequency of outbreaks may be conducive to the development of a quick and sensitive approach that can distinguish between live and dead loads of BCC. We have assessed an exo probe-based recombinase polymerase amplification (RPA) with 10 µM propidium monoazide (PMAxx) for selective detection of live/dead BCC cells in various concentrations of antiseptics (i.e., chlorhexidine gluconate (CHX) and benzalkonium chloride (BZK) solutions) after 24 h. The optimized assay conducted using a set of primer-probes targeting gbpT was performed at 40 °C for 20 min and shows a detection limit of 10 pg/µL of genomic DNA from B. cenocepacia J2315, equivalent to 104 colony-forming units (CFU/mL). The specificity of a newly designed primer and probe was 80% (20 negatives out of 25). The readings for total cells (i.e., without PMAxx) from 200 µg/mL CHX using PMAxx-RPA exo assay was 310 relative fluorescence units (RFU), compared to 129 RFU with PMAxx (i.e., live cells). Furthermore, in 50-500 µg/mL BZK-treated cells, a difference in the detection rate was observed between the PMAxx-RPA exo assay in live cells (130.4-459.3 RFU) and total cells (207.82-684.5 RFU). This study shows that the PMAxx-RPA exo assay appears to be a valid tool for the simple, rapid and presumptive detection of live BCC cells in antiseptics, thereby ensuring the quality and safety of pharmaceutical products.

Risk-based contamination control strategy of manufacturing non-sterile pharmaceutical products

Risk-based contamination control strategy of manufacturing non-sterile pharmaceutical products

Specific Detection and Enumeration of Burkholderia cepacia Complex by Flow Cytometry Using a Fluorescence-Labeled Oligonucleotide Probe.

Burkholderia cepacia complex (BCC) contamination has resulted in recalls of non-sterile pharmaceutical products. The fast, sensitive, and specific detection of BCC is critical for ensuring the quality and safety of pharmaceutical products. In this study, a rapid flow cytometry-based detection method was developed using a fluorescence-labeled oligonucleotide Kef probe that specifically binds a KefB/KefC membrane protein sequence within BCC. Optimal conditions of a 1 nM Kef probe concentration at a 60 °C hybridization temperature for 30 min were determined and applied for the flow cytometry assay. The true-positive rate (sensitivity) and true-negative rate (specificity) of the Kef probe assay were 90% (18 positive out of 20 BCC species) and 88.9% (16 negative out of 18 non-BCC), respectively. The detection limit for B. cenocepacia AU1054 with the Kef probe flow cytometry assay in nuclease-free water was 1 CFU/mL. The average cell counts using the Kef probe assay from a concentration of 10 μg/mL chlorhexidine gluconate and 50 μg/mL benzalkonium chloride were similar to those of the RAPID-B total plate count (TPC). We demonstrate the potential of Kef probe flow cytometry as a more sensitive alternative to culture-based methods for detecting BCC in non-sterilized pharmaceutical raw materials and products with regards to water-based environments.

A Propidium Monoazide (PMAxx)-Droplet Digital PCR (ddPCR) for the Detection of Viable Burkholderia cepacia Complex in Nuclease-Free Water and Antiseptics.

Pharmaceutical products contaminated with Burkholderia cepacia complex (BCC) strains constitute a serious health issue for susceptible individuals. New detection methods to distinguish DNA from viable cells are required to ensure pharmaceutical product quality and safety. In this study, we have assessed a droplet digital PCR (ddPCR) with a variant propidium monoazide (PMAxx) for selective detection of live/dead BCC cells in autoclaved nuclease-free water after 365 days, in 0.001% chlorhexidine gluconate (CHX), and in 0.005% benzalkonium chloride (BZK) solutions after 184 days. Using 10 μM PMAxx and 5 min light exposure, a proportion of dead BCC was quantified by ddPCR. The detection limit of culture-based method was 104 CFU/mL, equivalent to 9.7 pg/μL for B. cenocepacia J2315, while that of ddPCR was 9.7 fg/μL. The true positive rate from nuclease-free water and CHX using PMAxx-ddPCR assay was 60.0% and 38.3%, respectively, compared to 85.0% and 74.6% without PMAxx (p < 0.05), respectively. However, in BZK-treated cells, no difference in the detection rate was observed between the ddPCR assay on samples treated with PMAxx (67.1%) and without PMAxx (63.3%). This study shows that the PMAxx-ddPCR assay provides a better tool for selective detection of live BCC cells in non-sterile pharmaceutical products.

Microbiological Quality of Selected Local and Imported Non-Sterile Pharmaceutical Products in Dar es Salaam, Tanzania

BackgroundPathogenic and non-pathogenic microbial contaminants can cause physical–chemical alterations of pharmaceuticals and medicine-related infections. This study aimed to examine the microbiological quality of selected local and imported non-sterile pharmaceutical products in the Dar es Salaam market and the antibiogram of the isolated microorganisms.MethodsSamples were collected between April and June 2021 and analysed for microbial content as per the harmonised methods of the European Pharmacopoeia (EP). Antibiotic susceptibility of the microbial isolates was studied using Kirby-Bauer disc diffusion method.ResultsFifty percent (50%) of the samples failed both bacterial and fungal enumeration tests. In this study, local products recorded lower microbial counts than imported products. Major bacterial contaminants isolated were P. aeruginosa (45.5%), S. epidermidis, (45.5%) and K. pneumoniae, while major fungal contaminants were A. flavus (58.3%), followed by A. fumigatus (25%) and Penicillium spp (16.7%). The isolated bacterial contaminants recorded high resistance levels to commonly used antibiotics.ConclusionThe tested products were contaminated with microorganisms at different levels, most of them exceeding the maximum acceptable colony counts. Syrups or suspensions were more contaminated than tablets and capsules. The isolated bacterial contaminants were highly resistant to commonly used antibiotics.RecommendationsWe recommend that pharmaceutical manufacturers abide by good manufacturing, distribution and storage practices to limit contamination and cross-contamination of products. Responsible drug regulatory authorities should heighten the frequency of inspection of manufacturing facilities and regularly conduct post-marketing surveillance (PMS) of registered products to assess continued conformity to GMP guidelines. Future studies should involve samples collected directly from manufacturing sites.

Microbial and Physicochemical Analysis of Non-sterile Pharmaceutical Liquid Products in Karachi Pakistan

The pharmaceutical products and their therapeutic efficacy were comprised' due to the involvement of both physicochemical and microbial characteristics of the pharmaceuticals. However, liquid preparations are highly at risk due to the high percentage of sucrose contains that is beneficial for the growth of microbes. The inspection was to find to judge the microbial and physicochemical qualities of samples of paracetamol and cetirizine sold in Karachi, Pakistan. Three hundred fifty (350) pharmaceuticals brand were investigating; their organoleptic properties such as density, color, pH, test and total content of active ingredients, total viable count, and type of microbe of samples. These tests were conducted followed by the standard techniques and procedure. Assess the brands of paracetamol and cetirizine samples were meet the standard microbial specifications. The result of the organoleptic test was sweet, according to the color sample was found green, pink, red, yellow, and transparent liquids. The density of samples fluctuated between (1.150 - 1.390) g/ml. Similarly, the pH of the samples was recorded between (4.72 - 6.10). The active ingredient concentration of both samples was observed, ranging from 99% - 104%. The microbial limit many tests were conducted for the observation; the absence of 5 specified microbes in non-sterile pharmaceutical preparation. Pseudomonas sp. Escherichia coli (E-coli), salmonella spp, Staphylococcus spp, and Candida Albicans. All the samples of paracetamol and cetirizine were found contaminated under the acceptable limit. This observation explained that the ten brands of paracetamol and cetirizine sold in the pharmacy of Karachi Pakistan were complying with specifications of pharmacopeia, about both physicochemical and microbial characteristics analyzed dosage form fit for used and acceptable for pediatric and geriatric patients.

Measurement uncertainty evaluation and risk of false conformity assessment for microbial enumeration tests

Microbial enumeration tests are widely used to assess the microbiological quality of non-sterile pharmaceutical products. Despite of all efforts to guarantee the reliability of microbial enumeration tests, there will always be an uncertainty associated with the measured values, which can lead to false conformity/non-conformity decisions. In this work, we evaluated the measurement uncertainty using a bottom-up approach and estimate the consumer's or producer's risk due to the measurement uncertainty. Three main sources of uncertainty were identified and quantified: dilution factor, plated volume, and microbial plate counts. The contribution of these sources of uncertainty depends on the measured value of microbial load in pharmaceutical products. The contribution of dilution factor and plated volume uncertainties increase with an increase of measured value, while the contribution of microbial plate count uncertainty decreases with an increase of measured value. The overall uncertainty values were expressed as uncertainty factors, which provide an asymmetric 95% level confidence level of microbial load in pharmaceutical products. In addition, the risk of false conformity/non-conformity decisions due to measurement uncertainty was assess using Monte Carlo method. When the measured value is close to the upper specification limit and/or the measurement uncertainty is large, the risk of false conformity/non-conformity decisions may be significantly high. Thus, we conclude that the use of uncertainty factor in the conformity/non-conformity assessment is important to guarantee the reliability of microbial enumeration test results and to support decision-making.

Assessment of Microbial Qualities of Some Cough Syrups and Multivitamins Marketed in Pokhara, Nepal

Recently, the manufacturers of pharmaceuticals have improved the quality of non-sterile pharmaceuticals in such a way that such products contain only minimal bioburden. However, the production of sub-standard cough syrups and multivitamin syrups may cause non-therapeutic effect in patients, particularly in children. For this reason, this study was conducted to evaluate the microbiological quality of cough syrup and multivitamin syrups marketed in Pokhara, Nepal. Different brands of 15 cough syrups and 15 multivitamin syrups were collected from different vendors of Pokhara and the spread plate technique was performed to enumerate the microbial contaminant from the collected samples. Among 15 cough syrups, 12 samples were found to be contaminated with bacteria and nine samples were found to be contaminated with fungi. Similarly, among 15 multivitamin syrups, 10 were found to be contaminated with bacteria whereas 12 were found to be contaminated with fungi. Escherichia coli was not isolated in any samples. Overall, 14(93.33%) of cough syrup and 13(86.67%) of multivitamin syrups were found to be contaminated by either bacteria, fungi, or by both which exceeded the acceptance limit of International Pharmacopeia. The prevalence of these microorganisms in pharmaceutical products such as syrups samples may indicate the unhygienic condition, defect in production, poor adoption of Good Manufacturing Practice, ineffective preservatives and inadequate quality control. Though these products fall under non-sterile pharmaceutical products, so they need not require sterility but these drugs must conform to the microbiological purity criteria set in the appropriate pharmacopeial standard. These contaminated syrups explain the poor treatment and complicacy of the uncompromised people and the sick children.

A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products

This article aims to review available scientific data dealing with the Microbial contamination that may occur by some environmental factors (temperature, pH, and water activity), these factors are a major problem for the spoilage of pharmaceutical dosage form, and raw material, personnel, and other factor contributing to the transfer of the microbe into the pharmaceutical product. Non-sterile oral pharmaceuticals, including syrups, do not need to be sterile. At the same time, certain quality-control tests and some measures were followed, according to current good manufacture practice (cGMP), which are essential to keep the microbial content of these preparations safe and acceptable. Similarly, may manufacturer failures to comply with the Good Manufacturing Practice (GMP) at any stage of pharmaceutical production may consequently affect the microbiological quality of the product, and ultimately they caused economical loss for industrialists on the spoilage of pharmaceuticals. Microbial contamination in the pharmaceutical products increases from prescribed limits may change their Physico-chemical properties of the dosage form may be chances to hazardous for the immune-compromised patient due to overload microbial contamination. All the components of the non-sterile pharmaceuticals such as API and all kinds of excipients are at risk due to microbe overloaded and spoilage. Strictly the following (cGMP), continuous pharmaceutical surveillance is required to control microbial contamination within the pharmaceutical preparations.

Validation of Alternative Microbiological Method in Non-sterile Pharmaceutical Product Through the Reference Strains and Productive Environment Bioburden

The traditional methods described in pharmacopeias most commonly used by the pharmaceutical industry are easy to perform and the costs are affordable, but they require long periods of time to obtain the results and often do not present sensitivity for recovering microorganisms in vulnerable physiological states known as viable but nonculturable. Thus, the objectives of this study were to evaluate the potential applicability of flow cytometry in non-sterile pharmaceutical products. This paper implemented the analytical validation steps, through the reference strains and productive environment bioburden, by analyzing the traditional method in parallel to the alternative method with flow cytometry. The results indicated, with a 95% probability of detection, that there were no significant differences between the methods in relation to the ability to detect microbial contamination; however, the detection was faster with the flow cytometry method than the traditional method, which indicates that this technology is a viable alternative to be implemented. The study demonstrated that the alternative microbiological method presents greater sensitivity in the analyses carried out, guaranteeing greater patient safety, besides allowing results to be obtained in a short period of time, thus enabling anticipation of investigations on possible failures that may occur during the process. Additionally, the study contributes to the environment by reducing waste generation and saving energy.

Microbial Count of Non-sterile Pharmaceutical Products Sold in Pakistan

Microbial Count of Non-sterile Pharmaceutical Products Sold in Pakistan

Extemporaneous benznidazole oral suspension prepared from commercially available tablets for treatment of Chagas disease in paediatric patients.

To develop an extemporaneous 1% benznidazole (BNZ) suspension, with masked taste and adequate stability starting from available commercial tablets. The quality of compounding was evaluated through content uniformity measurement and physical and microbiological stability evaluation, under different storage conditions during 90 days. Six batches of 1% BNZ suspension were prepared using safe excipients currently available in a galenic area of Hospital Pharmacy and then stored at 5 and 25 °C for 90 days. The BNZ content was determined by UV spectrophotometry. Physical stability was defined as the absence of colour, odour and/or flavour changes and the re-suspension of solid phase by a reasonable amount of simple 15-s shaking. The compliance with microbiological attributes of non-sterile pharmaceutical products was also evaluated. An oral liquid suspension, containing 1% of BNZ, was developed from commercially available BNZ tablets. The formulations stored for 90 days were easily re-dispersed after a simple 15-s shaking, ensuring the pouring of a liquid volume containing the desired dose of BNZ. All samples were within the acceptable range of BNZ concentration with minimal standard deviations. There were no detectable changes in colour, odour, viscosity, pH and microbial growth, complying with official quality requirements. The quality attributes were not affected by storage, room or refrigeration conditions or by the frequent opening or closing of the multidose containers. Paediatric oral liquid suspension containing 1.0% of BNZ was easily prepared starting from commercial tablets, being an interesting alternative for optimising the paediatric treatment of Chagas disease.

Microbiological quality of non-sterile pharmaceutical products

In microbiological terms, pharmaceutical products can be divided into two groups: sterile and non-sterile. Non-sterile drugs must satisfy the appropriate microbiological purity criteria which are included in pharmacopoeial monographs. Pharmacopoeial studies are prepared specifically with a view to ensuring that the medicinal product is therapeutically effective and safe for the patient. The analysis comprised the results of microbiological purity tests performed before the products are marketed. Total of 1285 samples of non-sterile drugs manufactured by different pharmaceutical plants in Polish were taken into study. The microbiological quality of drugs was assessed in accordance with the criteria included in the European Pharmacopoeia (EP). An analysis of test results demonstrated that the percentage of non-compliant samples was 1.87%. The groups of drugs, which the most often did not satisfy EPs’ requirements, were drugs containing raw materials of natural origin (5.7%). The samples of studied drugs that did not meet the criteria contained in EP, exceed the maximum allowable microbiological count limits and contained microbes whose presence is prohibited. The most common non-compliance was the excessive levels of the maximum acceptable fungal count (n=12) and the excessive the maximum acceptable aerobic microbial count (n=10).

Evaluation of liquid and solid culture media for the recovery and enrichment of Burkholderia cenocepacia from distilled water.

Burkholderia cepacia complex (BCC) presence has been the cause of recalls of both sterile and non-sterile pharmaceutical products since these opportunistic pathogens have been implicated to cause infections to susceptible individuals. BCC are ubiquitous in nature, but in pharmaceutical settings the most common source is contaminated water systems. Some strains of BCC, previously described as Pseudomonas cepacia, were not readily detected by standard culture methods. We have explored different strategies to recover and enrich Burkholderia cenocepacia previously cultured in distilled water for 40days. Enrichment media of varied nutrient concentrations and composition were used, including modified Tryptic Soy Agar or Broth (TSA or TSB), Reasoner's 2nd Agar or Broth (R2A or R2AB), Brain-Heart Infusion Broth (BHIB), Mueller-Hinton Broth (MHB), and Ashdown's (ASH) medium. Of the various broth media tested, cell growth was significantly greater in TSB and R2AB than in BHIB, MHB, or ASH broth. TSB and R2AB were also compared for their recovery efficiency. Generally, there was no significant difference between the numbers of B. cenocepacia grown on 15 differently modified TSA and five modified R2A solid media. Overall, however, diluted TSA and TSB media, and R2A and R2AB showed better recovery efficiency than TSA and TSB for inocula containing small numbers of cells. All strains persisted in distilled water for 40days. Broth media were more effective than solid media for recovery of B. cenocepacia from distilled water. These results may assist in improving detection assays with recovery and enrichment strategies to maximize recovery of these fastidious organisms.

Microbial quality of some non-sterile pharmaceutical products sourced from some retail pharmacies in Lagos, Nigeria

Eight drugs on sale in five community pharmacies in parts of Lagos State were evaluated for microbial quality using standard procedures. A total of 40 samples were screened and 24 bacteria isolates, comprising 12 cocci and 12 bacilli were isolated. The cocci comprise 9 staphylococci and 3 micrococci while the bacilli constitute of 10 Bacillus species and 2 clostidia. Fungal isolates included Saccahromyces species, filamentous fungi; Aspergillus,Penicillium, and Microspora mostly from tablets in the multidose pack. Total bacterial counts for tablets in multidose and blister packs ranged from 1.0 × 102 to 9.0 × 102 CFU/g and 0 to 2 CFU/g respectively. Total yeast counts for tablets in multidose packs ranged from 1.4 × 102 to 9.0 ×102 while those of blister packs were between 0 to 6 CFU/g. Higher values of both the bacterial and fungal counts were obtained from drugs in multidose packs including ascorbic acid, paracetamol, gelucil, folic acid and multivitamin. The antimicrobial susceptibility tests showed that the Staphylococcus aureus were susceptible to amoxicillin and cotrimoxazole but resistant to other antibiotics tested, indicating a common source contamination. Key words: Microbial quality, non-sterile, pharmaceutical products.

Frequency and antimicrobial resistance of bacteria isolated from oral and topical medicaments from Hilla, Iraq

The presence of microorganisms in pharmaceuticals is undesirable because they may cause spoilage of the product and may present an infection hazard to the consumers or patients. A total of 102 samples of oral and topical non-sterile pharmaceutical products were collected at random from different drug houses and pharmacies in Iraq, to investigate the microbial contamination of these products. Bacterial isolates recovered from these medicaments were subjected to susceptibility testing against various antibiotics by disk diffusion method according to Clinical and Laboratory Standards (CLSI) guidelines. The results revealed that the occurrence of gram-positive bacteria was in oral and topical medicaments while gram-negative bacteria were only detected in topical medicaments. More than 58% of Bacillus isolates were resistant to lincomycin and Bacillus mycoides isolates were resistant to beta-lactam antibiotics and trimethoprim-sulfamethoxazole. Staphylococcus spp. showed a relatively high resistance to ampicillin, amoxicillin, penicillin, tetracycline, and trimethoprim-sulfamethoxazole. S. epidermidis had the highest number of multi-resistant isolates. Furthermore, 87.5% of isolated gram-negative rods showed high resistance to beta-lactam antibiotics and 75% of them were highly resistant to erythromycin. One isolate of Pseudomonas aeruginosa was the most resistant among all gram-negative rod isolates. The high rate of resistance to antimicrobial agents of bacterial isolates recovered from oral and topical medicaments in this study may indicate a widespread antibiotic resistance among bacteria isolated from different sources, including those of anthropological and environmental origin.