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Updated: Jul 14

Peer Review Article | Open Access | Published 11th July 2025


Pharmaceutical Industry Manufacturing Trend for Tablet Dosage Forms and Opportunities for the Future; A Case Study of Current Practice and Future Developments

Tarang Patel¹ , Vatsal Patel ², Mehul Patel ³ *, Umang Shah³, Ashish Patel³, Swayamprakash Patel⁴, Nilay Solanki⁵ . | EJPPS | 302 (2025)| https://doi.org/10.37521/ejpps30208 


 

Abstract 

The oral route of giving medicine is a well-liked, practical, and generally approved way of drug delivery. With the introduction of pre-compression, the ultra-high-speed press, and induced die feeding during the last several decades, the formulation of solid oral dosage forms has improved. The federal regulations and concepts pertaining to bioavailability, bioequivalence, and validation have had an influence on tablet formulation, design, and production. In today's world, there are numerous divisions involved in manufacturing tablet dosage forms, which include the material store, dispensing area, slagging, granulation and lubrication, bin charging, compression, and coating, work in process (a general term for partially finished goods), inspection rooms, primary and secondary packaging areas, documentation cell, human resource area, and quality assurance, microchemical labs, quality control labs, laboratories for validation, stability testing, and many more. In the future, industrial facilities will rely heavily on machines like AGVs, AI robots, hydraulic arms, and other automated equipment that are programmed to perform tasks with very high-quality standards. Although some human involvement will still be needed for checking and verifying processes, most of the work will be carried out by these machines, reducing the need for a large number of human workers to complete the manufacturing process of tableting.

Keywords: Tablet Manufacturing plant, Quality Assurance, Production, Automation, Pharmaceutical industry.

 

INTRODUCTION 

Oral administration is more frequently used than intravenous administration because it is non-invasive and more suitable for long-term therapy. The bulk of oral drugs are ingested; a tiny subset, though, are intended to dissolve in the mouth. When compared to alternative approaches, the oral route of medication administration is the most popular and has been used successfully for conventional drug delivery. It is recognized as the most organic, simple, useful, and secure way to take drugs. Additionally, it gives more design flexibility for dosage forms, is easier to make, costs less, and is both practical and secure.


For oral drug delivery, there are numerous pharmaceutical dosage forms available. The most popular forms of medication are tablets, capsules, different types of medicinal solutions, emulsions, and suspensions. When it comes to oral administration, solid dose forms are the most popular kind of drug. They are easily produced, stored, handled, and administered. They are somewhat stable, adjustable in terms of dose strength, and less challenging in terms of formulation and packing. The medicine is best protected from light, temperature, humidity, oxygen, and stress when it is transported in solid dosage form. One of the most popular solid oral dose formulations is the tablet. Tablets are solid pharmaceutical dosage forms that can be formed by compression and contain one or more medications, along with or without appropriate excipients.¹


Tablets are widely manufactured by the pharmaceutical industry. The production process involves direct compression, dry granulation, and wet granulation. Dry granulation can be used when materials are naturally cohesive or sufficiently bonded together to form granules without the help of liquids. Direct compression is the process of creating tablets by directly compressing an API powder mixture with the proper excipients. By wetting down the excipients and API with the granulation liquid, with or without a binder, the wet granulation generates the granules.


Direct compression is regarded to be the most effective approach since it just requires dry blending and compaction of API with essential excipients, reduces processing time and labour costs, and requires fewer production stages, less equipment, and less process validation than other procedures. Additionally, it reduces energy consumption, removes heat, and improves particle size homogeneity for moisture-sensitive APIs while also enhancing stability ². Blending is done according to the demands of the products. 


The tablet's direct compression and tableting processes involve significant energy consumption and time; more importantly, they emit greenhouse gases (GHGs) into the atmosphere. Eliminating a range of organic solvents from pharmaceutical production processes can improve atmospheric emissions ³⋅⁴.Pharmaceutical manufacturing is just one of several sectors placing considerable emphasis on process improvement and technological advancement to reduce environmental impact and enhance production efficiency ⁵


Despite being part of the pharmaceutical production industry for almost 50 years, microfluidics (MFs) have not yet realized their full potential. Their application has only recently begun to be adequately implemented, yielding world-class results in component analysis and formulation manufacture. From an environmental perspective, microfluidics have emerged as a promising pharmaceutical technology for future investment due to the reduced use of materials during processing and the consequent decrease in waste generation ⁶


This paper describes the current industrial production practices as carried out in a specific manufacturing plant, a particular facility with which the author is familiar. Future developments in the field of tablet production will then be considered.

In the current study, the production of tablets using the present approach involves a number of departments, from material storage to the dispatch of goods. Artificial intelligence, AGVs, machine learning, and robotic arms have the potential to have a beneficial effect on human civilization however they will eliminate the need for individuals to be involved in the production of better-quality products.

 

Current Industrial Production Developments for the Tablet Manufacturing Plant. ⁷

The process of making tablets begins with the purchase of API from a merchant. The designated party from the list of identified vendors verifies the item as it is brought inside the building via conveyor belts from the truck, where it is then checked by the production and store departments. The right entry is made, and QC personnel are requested to sample the API and excipients. Through a method outlined in accordance with corporate policy, the material sample is made. Various items, such as LOD, % assay, material appearance, material code, product name, manufacturer name, and storage conditions are evaluated in compliance with the manufacturer's Certificate of Analysis (COA).


After verification of material and API, there are three possibilities: accepted, rejected, or damaged product. Once the product is accepted then it is stored at the appropriate location specified in the system and data entry is made by store personnel. If the material is found to be damaged the manufacturer is informed. If material is out of the limits of CoA, then it is rejected and sent back to the manufacturer with a material rejection slip and other official documents so that appropriate action should be taken to reduce errors. Once material is accepted it is stored according to storage conditions and entry is made in a system according to the first-in and first-out basis. Every hour, a computer attached with temperature sensor is used to make the proper entry and store the data for the storage facility which would monitor temperature differences inside the storage facility. If there is any fluctuation in temperature, a warning is sent to the store to ensure that the temperature is kept at the proper level as even a small change in temperature can cause the product to degrade.


Dispensing, the beginning phase of tablet manufacture, involves finalizing batch plans with the Human Resources department and printing BMR from the documentation cell (a dedicated team or department that is responsible for the management and control of all documentation related to pharmaceutical products and processes is referred to as a documentation cell). The production, store, and quality assurance teams review the program in the computer and then calculate the API and excipients based on different batch numbers. The calculations include batch sizes, and if material is left, it is carried forward to subsequent batches of the same product.  After the batch calculation is complete, it is transported to the dispensing area. The QA, production, and store staff verify the authorised number and material code written on the material, and then they enter the relevant data into the BMR according to the batch-specific weight.


Batch manufacturing begins following the verification of records and the planning coordinated by the Human Resources department. Initially, the dispensing area is cleaned by designated employees under the supervision of production personnel. Once the cleaning process is completed, quality assurance personnel review and approve the area before manufacturing proceeds.


Excipients and API are sent into the dispensing area from the material entry doors after quality assurance approval. Weighing of the material takes place in the presence of quality assurance, store personnel, production personnel, and skilled helper worker once the API, excipients enter in the dispensing room. There are two different kinds of dispensing rooms, with separate rooms allocated for dispensing liquid and solid dispensing rooms. Inside each batch, the API is dispensed after the excipients, and the appropriate weight label is affixed. The reason behind that is that particles may stay suspended in the environment whenever we open or expose any container in the dispensing booth and weigh it, and they may settle in API containers when we dispense active pharmaceutical ingredients.


Since most excipients used in different batches are identical, there won't be any risks when they combine with API containers because the excipients are inert. API-suspended particles will contaminate the excipient if the API is dispensed first, followed by the excipients. As is well known, a variety of excipients are utilized in various products, and the use of contaminated excipients in other items can be extremely harmful, particularly when it comes to potent drugs, hence for this reason the API is dispensed at the end of the process. Separate liquid dispensing rooms are used for dispensing liquid material. API or light-sensitive material is dispensed in black bags. Equipment located in the dispensing room includes a dispensing booth, hydrometer, weighing scales, and a computer with a label printer. APIs and excipients are placed into the dispensing bins according to each unique batch. Bins are distributed via the material entrance and departure rooms that are located inside the tagging room. The excipients and API of each batch in the staging room are to be destroyed if they remain in the room for more than 15 days after dispensing.


Production personnel and Quality Assurance check the batch labelling, batch manufacturing records, weighing balance calibration, and differential pressure logbooks.

The next process is granulation, followed by lubrication and first-line clearing of the granulation room. Everything on the checklist such as the differential pressure logbooks of the area, machine validation status, cleaning time, cleaning reagent, sieve sizes, cleaning of the fluid bed dryer bags and other items is checked by a member of production and verified by a member of the Quality Assurance team.

Once the dispensing bins are transported to the granulation area by helper workers, the bins are opened, and production personnel weigh the API and excipients again with the assistance of qualified helpers. The accuracy is then verified by individual Quality Assurance personnel. Items such as tare weight, gross weight, label verification, product code, product quantity, and product description are reviewed as part of the granulation area weighing according to the checklist.


Inside the granulation room, there is equipment such as a sieving machine, ball mill, hammer mill, rapid mixer granulator, fluid bed dryer (FBD), moisture analyser, hydrometer, and others. After verification, the excipients and API are added to the roller mill as per the individual BMR recipe, and the process is carried out by the production personnel. Next, the material is passed through a sieving machine to reduce its size. As per the recipe, the API and excipients are then added to the rapid mixer granulator. Once the dough is prepared, it is transferred to the fluid bed dryer. After 5–10 minutes of drying, a small sample is sent to the moisture analyser. If the moisture content is less than 1.5%, the bin is sent to the lubrication area, otherwise it is returned to the fluid bed dryer for further drying. The status board is updated, the bin is shifted to the lubrication area, and RPM and other parameters are manually recorded by the production personnel. These entries are verified by the member of Quality Assurance personnel.

Lubricant materials are added to the V-shaped blender after a few rotations. Once the lubrication process is complete, two samples are taken from the bin to check for mix uniformity and content uniformity as per BMR specifications. Samples are collected using a sampling rod at various points inside the bin. The BMR, differential pressure logbooks, and sampling book are properly filled out and approved by the Quality Assurance department. After sampling, the blended bin is stored in the bin charging area using hydraulic systems and lifts.


Blend that has been finalized after lubrication is stored in bin charging areas according to batch numbers, product specifications, and product storage. Line clearance of the compression and bin charging areas comes immediately. In accordance with the checklist listed in the BMR, such as cleaning of instruments, and validating the weighing balance, logbooks, and differential pressure logbooks, line clearance is granted by Quality Assurance in the presence of a production employee. Instruments such as the Roche friability, hardness tester, uniformity of weight machine, and parts of tablet punching machine verification are included in the IPQA Lab. There are a number of instruments that are utilized in the compression area, including a tablet punching machine, a deduster instrument, a weighing scale, a metal detector machine, and a digital hydrometer.


The inlets of the tablet punching machine are connected to the bin charging area to allow smooth powder flow. Production and helper personnel set the dies, punches, and other components, and their setup is verified by a designated In-Process Quality Assurance (IPQA) team member. In the pharmaceutical manufacturing context, In-Process Quality Assurance member is responsible for conducting quality checks and monitoring processes during production to ensure compliance with standards. In contrast, the broader Quality Assurance (QA) function involves activities such as issuing batch manufacturing records (BMR), preparing standard operating procedures (SOPs), and reviewing BMRs and batch packaging records (BPRs) after batch completion, along with other quality-related responsibilities. After the machine is assembled, In-Process Quality Control (IPQC) tests such as friability, weight variation, and hardness are performed on both the right-hand side (RHS) and left-hand side (LHS) machines. Samples are collected and analysed every 2 hours ± 15 minutes.


Various tablet defects such as peeling, lamination, picking, discoloration, and others are inspected and recorded. As the tablets exit the left-hand side (LHS) and right-hand side (RHS) of the tablet press, they pass through a metal detector and a deduster. Once cleared, the tablets are collected in properly labelled plastic containers, which are then transferred to the coating area. After line clearance of the coating area is completed, tablets are loaded into the coating pan. Line clearance involves checking differential pressure, validating the coating pan and hydrometer, calibrating the weighing balance, and confirming other parameters specified in the BMR. These tasks are performed by production personnel and approved by Quality Assurance. The coating area contains equipment such as a weighing balance, coating pan, and hydrometer. There is a separate coating preparation room and an IPQC room, where in-process samples are tested by the member of the Quality Assurance team.


The entire batch of tablets is loaded into the inlet of the coating pan, and the outlet is kept closed. The pan rotates in accordance with the RPM and flow rate of the coating material mentioned in the BMR, and the coating solution is sprayed into the pan using a spraying gun. At the same time, hot air is blown through the input holes, and excess hot air is expelled through the outlet holes. The coating procedure is carried out in accordance with BMR, and it may vary from batch to batch and product to product depending on the coating material utilized for each batch. A sampling slip is created, in which the sample size and batch data are provided. Once the coating has been completed, the item is brought to the inspection area where, in the presence of certified inspectors and the production team, the QA person provides line clearance of the inspection area in compliance with the checklist.


An automatic machine assembly is used, where coated tablets are inserted through the inlet. Using a computerized system, tablets with defects such as weight variation or coating issues are automatically rejected, and only acceptable tablets are discharged through the outlet and collected in bins. In addition, there are manual inspection rooms where staff visually check the tablets placed in plastic containers. These containers are then sent to the Work-in-Progress (WIP) area. The WIP area serves as a storage location where batches are recorded appropriately based on batch size. Within 24 hours, the tablets are transferred from the WIP area to the primary packaging area. Suitable batches are arranged on racks according to the numbers specified in the BMR, and this is confirmed by production personnel, store personnel, and Quality Assurance. Line clearance for both primary and secondary packaging areas is conducted simultaneously, depending on the specific product requirements. Before packaging begins, materials are allocated, and once the line clearance is completed, the assigned materials are loaded into the packaging assembly. The processes inside the packaging area are under the control of the members of store person, production personnel, and quality assurance personnel.


The primary packaging area contains the following equipment:

  • Roll size

  • Boxes (avoided repetition)

  • Temperature and humidity

  • Labels

  • Shipper label

  • Barcode

  • BOPP film roll

  • Weighing balance

  • Aluminium roll

  • Machine validation due date

  • Personnel working in the premises

  • Previous product check


The secondary packaging area contains the following equipment:

  • Weighing scales

  • Hydrometers

  • Labelling equipment

  • Carting equipment

  • Shipper label printing equipment

  • Racks for storing finished items


When the batch begins, samples are taken from the start of the batch. Samples are also taken in the middle and at the end of the batch. These samples are sent to the QC department for online testing and stability testing.


The racks are immediately moved from the packaging area to the storage area. Products are stored in the storage area as directed by the BMR. After receiving permission from the HR personnel, products are loaded into trucks and sent to distributors. Various stages involved in the tablet manufacturing process are shown in  Figure 1.                     

Figure 1: Stages of Tablet manufacturing process
Figure 1: Stages of Tablet manufacturing process

Future Scopes in Industrial Production Developments for the Tablet Manufacturing Plant ⁷

Future tablet production facilities will be mechanized to enable pharmaceutical plants to implement Six Sigma requirements. Automated Guided Vehicles (AGVs) will transport the API and excipients to the production facility. The product will be lifted by cranes using automated hydraulic arms and placed on conveyor belts. Machines will scan the barcode and confirm that the material matches the coding defined in the Drive. After being scanned by robotic arms, the items will be placed in the in-process quarantine room. Robotic arms will be used to sample the API and other materials. Through autonomous systems, the samples will be sent to quality control labs where robots will analyse them.


If there is a problem with the material, there will be three options: pass, reject, or send the material back to the supplier. The material will be considered passed when it meets all the required tests, such as LOD, Assay, and other specifications. Rejections will occur if the analysis results do not meet the system-specified requirements. If there are issues with the batch code, quantity, or other details from the API and excipient manufacturer, the material will be sent back. After passing the inspection, the material will be moved to the proper storage location by an AGV equipped with robotic arms, having been transported there by conveyor belts.


When the plan comes from the Human Resource department, the automatic BMR will be displayed on the screen in the dispensing area. Artificial Intelligence will make the appropriate calculations of API and excipients. Robotic arms will make the necessary entries, and the cleaning of the dispensing area will be completed while all controls are monitored. Through the Automated Guided Vehicle (AGV), the material will be sent from the store to the dispensing area, where the dispensing of materials will take place. After dispensing is complete, appropriate record sheets will be generated, listing all controlled parameters. This data will be stored inside the computer and controlled by machines. If any defects are observed, the material will be immediately discarded. The material will then be sent to the slagging rooms, where it will be stored for 24 hours. An automatic system will scan the material and select the batch for the next step, which is granulation. AGVs will verify the dispensed material by scanning the barcode before allowing it to enter the granulation area.


Clearance will be granted by the automatic systems and the on-site Quality Assurance person before the approved material is placed inside the granulation area line. Once the line is cleared, material will be delivered to the granulation area using AGVs. The entire BMR operation will then be carried out by the hydraulic arms. All steps, such as size reduction, rapid mixture cum granulation (RMG) dow production, shifting the bins from RMG to FBD after dow production, and collection of samples from FBD for moisture checking, will be automated within the system. However, quality inspectors will check the machinery to ensure it is in good working order. If any defects or system errors are discovered, the entire manufacturing process will be stopped.


If everything appears to be in order, the material will be moved to the lubrication section. A single bin will be connected to the lubrication blenders and rotated for the appropriate amount of time. Robotic arms will collect samples to check the consistency of the mix and the uniformity of the weight from the stainless-steel container once the process is complete. The bin will then be moved to the bin storage area. The barcode will be scanned and the bin will be transferred to the compression area after the proper processing steps are completed.


The appropriate weight will be entered into the system before the compression point. Once the weight is entered, the material will be delivered to the area above the compression point for filling. Robotic arms and a computer coding machine will handle the line clearance of both the compression and intake areas simultaneously. The robotic arms will be used to position and control the punches, dies, and other tools.

Tableting will begin on a machine within the compression area once Quality Assurance has personally inspected the entire system to ensure everything has been done according to the checklist. Robotic arms will collect various in-process samples, which will then be sent to QC for analysis.


After the coating area’s line has been cleared, compressed tablets will be placed inside the coating pan, where the coating will be carried out automatically utilizing hydraulic arms. The hydraulic arms will gather in-process samples, which will then be tested in labs. Other QC samples will also be collected. Once the coating process is complete and verified to meet product specifications, the batch will be sent to the inspection area. The coated tablets will be stored in appropriately labelled stainless-steel bins, based on batch size and capacity.


The coated tablets will then be transferred to a machine assembly system analyser where various defects, including coating errors, weight defects, and other issues, will be eliminated. The analyser will distinguish undesirable pills from acceptable ones, placing the good pills in the stainless-steel bins. The defective pills will be discarded after the batch is finished. The bins will then be moved into the work in progress (WIP) area at the designated locations using AGVs.


The finalized tablets will be kept in the WIP section. The batch will be transported to the primary and secondary packing locations as per system planning. Machines will grant line clearance in the primary and secondary packing areas, and an inspector will verify that everything is in accordance with the parameters listed in the BMR checklist. Once the batch has been verified by a Quality Assurance team member, it will start the next phase. Tablets will be inserted into the blister machine through hydraulic arms, where the blisters will be formed, collected, and packaged inside boxes.


Through conveyor belts, the blister-packed boxes will be placed into larger cardboard cartons using robotic arms in the designated area. To ensure proper identification, labels and barcode stickers will be automatically applied to the cartons. These boxes will then be mounted on racks using hydraulic arms at the locations specified in the BMR. Robotic arms will also collect in-process, stability, and retained samples, which will be sent to the Quality Control (QC) department for evaluation. Once approved, the finished goods will be transferred to the designated storage areas. Later, various forms of transportation will be used to deliver the full batch to market destinations.


CONCLUSIONS

The oral route is a popular, useful, and widely accepted method of drug administration. The majority of the population uses this route without any hesitation. But the tablet preparation process and its handling is a complex process. The planning, management, and maintenance of the tablet production factories are all performed by humans at the present level. Whilst many current pharmaceutical manufacturing techniques are only semi-automated, fully automated systems are expected to become more common in the future. Initially, such systems may face errors due to setup complexity and calibration issues. However, once optimized, these systems will offer consistent, high-quality output and uninterrupted 24/7 operation, minimizing human error and downtime. Although automation may reduce certain manual job roles, it will create new opportunities in areas such as system maintenance, robotics oversight, and data analysis. In-person Quality Assurance (QA) inspectors will remain essential to monitor system performance, verify product quality, and intervene when automated systems encounter anomalies.


Informed Consent Statement:

No animals or humans were harmed during the study

 

Conflict of interest

The authors declare no competing interests in this work.

 

Funding

This research paper does not receive any financial support.

 

Written consent for publication

All the authors approved to publication this manuscript.

 

Author Contributions:

All authors have contributed equally

Data availability

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

 

Code availability

Not applicable

 

Acknowledgment

The authors are grateful to Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421, India, The Arnold & Marie Schwartz College of Pharmacy and Health Sciences Long Island University, Brooklyn, New York City- 11201, USA and Sardar Patel Collage of Pharmacy, Sardar Patel Education Campus, Vidyanagar- Vadtal Road Bakrol, Gujarat, India for providing all the necessary facilities to complete the work.


References


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03. Boltic, Z.; Ruzic, N.; Jovanovic, M.; Savic, M.; Jovanovic, J.; Petrovic, S. (2013) Cleaner production aspects of tablet coating process in pharmaceutical industry: Problem of VOCs emission. J. Clean. Prod, 44, 123–132.

04. Basu, S.; Mukhopadhyay, S.K.; Gangopadhyay, A.; (2013) Dastidar, S.G. Materials Saving and Waste Minimization in Indian Pharmaceutical Industries. Res. J. Pharm. Sci, 2, 20–25.

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Authors

Dr. Mehul Patel


Corresponding Author: Dr. Mehul Patel

Department of Pharmaceutical Chemistry and Analysis, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421, India.

                                      

                                           Email:         mehulpatel.ph@charusat.ac.in       

                                         

Tarang Patel1 , Vatsal Patel 2, Mehul Patel 3 *, Umang Shah3, Ashish Patel3, Swayamprakash Patel4, Nilay Solanki5 .

 

1 Department of Pharmaceutical Sciences, The Arnold & Marie Schwartz College of Pharmacy and Health Sciences Long Island University, Brooklyn, New York City- 11201, USA.

2 Department of Pharmaceutics, Sardar Patel College of Pharmacy, Sardar Patel Education Campus, Vidyanagar - Vadtal Road Bakrol - 388 315, Gujarat 388315,India

3 Department of Pharmaceutical Chemistry and Analysis, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421, India.

 4 Department of Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421, India.

5 Department of Pharmacology, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, CHARUSAT Campus, Changa, Gujarat-388421, India.

 

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