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Validation is the procedure which authorizing documentary evidence that proves the following process will consistently produce the product which leads to the expected result. According to GMP validation studies are important part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. Validation is the one of the important part in achieving and maintaining the quality of the final product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP. Validation and quality assurance will go hand in hand, ensuring the thorough quality for product. Process validation plays a key role in the pharmaceutical manufacturing process as it delivers a high degree of assurance and evidence that the process, which is being carried out gives out the uniform results, that is, it means the required specifications, which has been performed accurately. The purpose of this review is to present an introduction and general review on validation in pharmaceutical industry.

The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.

Chromatography is an important biophysical process, allowing the components of a mixture to be isolated, classified and extracted for qualitative and quantitative analysis. Proteins can be purified based on features such as size and shape, total charge, surface hydrophobic groups and stationary phaset binding ability. Four separation strategies based on molecular characteristics and form of interaction Four separation techniques based on molecular characteristics and form of interaction use ion exchange mechanisms, surface adsorption, partition, and exclusion of the size. Column chromatography is one of the most common methods of protein purification Chromatography is based on the theory of separation of fluid stationary phase (stable phase) when traveling with the support of a mobile phase. The variables that are involved in this separation process include adsorption (liquid-solid), partition (liquid-solid), and affinity or variations between their molecular weights. Due of these variations, certain components of the mixture stay in the stationary phase longer, and travel gradually in the chromatography system, while others move rapidly through the mobile phase, leaving the system faster. Based on this method, three components form the basis of the chromatography technique. Stationary phase: is a phase consisting of a "solid" phase or a "solid surface adsorbed layer" Mobile phase: is a phase consisting of a "liquid" or a "gaseous part." Separate molecules which form the interaction between stationary phase, mobile phase and substances contained in the mixture are the basic component that is successful in separating molecules from the partition-based chromatography methods are very effective in separating small molecules and distinguishing them as amino acids, carbohydrates and fatty acids. In the separation of macromolecules as nucleic acids and proteins, however, affinity chromatography’s (i.e. ion-exchange chromatography) are more efficient. Paper chromatography is used in protein separation and protein synthesis studies; gas-liquid chromatography is used to isolate alcohol, ethanol, lipid, and amino groups, and to analyze enzymatic interactions, while molecular-sieve chromatography is used in particular to evaluate molecular protein weights. Agarose gel chromatography is used to purify RNA, DNA particles, and viruses. The chromatography stationary phase is a solid phase or liquid phase that is sprayed on a solid phase surface. A gaseous or liquid phase is a mobile phase which flows through the stationary phase. If the mobile phase is liquid, it is called liquid chromatography, and if it is gas, it is called gas chromatography. of gases and mixtures of volatile liquids, and solid material, gas chromatography is used. Liquid chromatography is used in particular for thermal unstable and non-volatile materials. The purpose of applying chromatography, which is used as a quantitative analysis tool apart from its separation, is to record a sufficient separation within an acceptable time interval. Various chromatography methods have been developed to that end. Some of these have chromatography on columns, thin layer chromatography (TLC), paper chromatography, gas chromatography, ion exchange chromatography, gel permeation chromatography, liquid high pressure chromatography, and affinity chromatography.

The body undergoes numerous physiological changes during pregnancy in order to provide an adequate environment for fetal development, meet the increased metabolic demands and prepare for childbirth Pregnancy is a natural but altered physiological state resulting in major changes in cardiovascular system, respiratory system, endocrine system, reproductive system and skeletal and bone changes. The body undergoes a number of physiological changes over the course of pregnancy. For both doctors and patients, the cutaneous findings may be most obvious and sometimes alarming. Obstetricians and dermatologists ought to be able to differentiate between normal changes and unhealthy ones. The pregnant mother undergoes essential physiological changes during pregnancy in order to support and accommodate the developing fetus. These modifications start after conception and affect every organ system in the body. This review underlines the major changes that occur during normal pregnancy.

The aim of present work research work was formulation and evaluation of stable montelukast sodium sublingual tablet. Since The thermal stress testing study of Monte in solutions at 65°C showed that it is highly stable in NaOH solution, while it degrades rapidly in both acidic and H2O2 solutions. Hence lyophilization technology was adopted to increase the stability of montelukast sodium. Before lyophilization three trials were carried out to optimize the process parameters in which Trial 2 was considered as optimized process. The Lyophilization was carried out in nine different batches by varying the total cycle time, freezing and holding time, primary drying and secondary drying time by maintaining the quantities of all the active pharmaceutical ingredients constant and selection of cryoprotectant ratio. An optimized lyophilization cycle of 56 hours has been achieved. The optimized lyophilized product was subjected to Tablet compression. In this process the batch-9 formulation was considered as an optimized Formulation for compression with the process. All the in-vitro evaluation parameters complies the limits as per the specification. Stability studies were conducted and from the result it was concluded that the optimized formulation was found to be stable. Finally, it is concluded that the lyophilization is a suitable technique to increase the stability and bioavailability of Montelukast sodium.

Analytical method development and validation play an important role in the discovery, development and manufacture of pharmaceuticals. This research paper described a simple, selective, linear, precise and accurate UV Spectroscopic method was developed and validation for the estimation of Montelukast sodium from bulk and tablet formulations.

A high performance liquid chromatography method has been developed and validated method for the simultaneous estimation of Montelukast sodium in bulk and tablet dosage form. The method was carried out using Princeton SPHER ULTIMA C18 100A 5μ 250*4.6 mm using OPA: Methanol (10: 90 v/v) as mobile phase at flow rate 1ml/min. HPLC separation was carried out at 284 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9982 and 0.9979 for Montelukast sodium in bulk and tablet dosage form respectively in the concentration range of 1–6 μl/ml for Montelukast sodium in bulk and tablet dosage form. The method was validated for precision, robustness, specificity and accuracy. The limit of detection and quantitation were 0.0011 and 0.0033 μg/ml. the proposed HPLC method can be applied for identification and quantitative determination of Montelukast sodium in bulk and tablet dosage form.