A review article on “process validation of pharmaceutical dosage form”
Keywords:
process validation, FDA, cGMP, USFDA, QMS, pharmaceutical, qualityAbstract
Quality is continually a vital prerequisite while consider any product. consequently, drugs must be manufactured to the very best exceptional levels. Validation is part of the exceptional warranty application and is fundamental to an efficient production operation for constructing first-class into the goods. Validation of the individual steps of the strategies is called the process validation. method validation entails the collection and evaluation of records, from the procedure design degree during manufacturing, that set up medical proof that a process is capable of continually turning in a high-quality drug substance. The purpose of the validation is to make certain that quality is constructed into the system at every step, and not just examined for at the stop. It includes the collection and assessment of facts, from the method design degree at some point of production, that set up scientific evidence that a procedure is able to always handing over a pleasant drug substance. method validation is an essential part of excellent guarantee as consistent with cGMP. Validation and great assurance will go hand in hand, ensuring the thorough quality for the products. as a result, an emphasis made on to study that offers a detailed, evaluate of validation.
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References
Sharma V, Rana A C, Seth N (2013) Industrial process validation of solid dosages form A review. Int Res J Pharm 4(5): 67-70.
Sarvani V, Elisha RP, Nama S, Pola LM, Rao CB (2013) Process validation: An essential process in pharmaceutical industry. International Journal of Medicinal Chemistry & Analysis 3(2): 49-52.
Aswal N, Joshi P, Choudhary A, Kothiyal K (2013) Prospective Validation of Paracetamol Tablet Dosage Form. International journal of pharmaceutical and chemical sciences 2(3): 1416-1425.
Nash R A, Wachter AH (2003) Pharmaceutical Process Validation, (3rd
edn). Marcel Dekker, Inc, New York, USA.
Rockville, M (1987) Guideline on General Principles of Process
Validation. US FDA.
Varshney P, Shah M, Patel P, Rohit M (2013) Different Aspects Involved In Process Validation. Innovare Journal of Science 1(2): 16-19.
Chaitanya kumar G, Rout RP, Ramtake S, Bhattacharya S (2005) Process
Validation. The Indian Pharmacist 14-19.
Sharma S, Singh G (2013) Process validation in pharmaceutical industry an overview. Jour Drug Del & Ther 3(4): 184-188.
Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation, PIC/S September, 2007.
http://pharmaceuticalvalidation.blogspot.in/2010/02/validation- essential-quality-assurance.html
Guidelines on General Principles of Process Validation (1987) CDER, USFDA
Nikam UA, Jadhav AV, Salunkhe VR, Magdum CS (2013) An Overview of Pharmaceutical Process Validation of Solid Dosage Form. Current Pharma Research 3(2): 824-835.
Peck GE, Anderson NR, Banker GS (1990) Principles of Improved Tablet Production System Design. In Lachman L, Lieberman HA, Schwartz JB (Eds.), Pharmaceutical Dosage Form. (2nd edn). Marcel Dekker Inc, New York, USA, p. 1-74.
Jena S, Arjun G, Anil NVR, Satish DK, Vinod KR, Banji D (2010) Industrial Process Validation of Solid Dosage Forms An Overview. International Journal of Pharmaceutical Sciences Review and Research 4(2): 145-
Sharma T (2012) Basic Aspects of Process Validation of Solid Oral Dosage Forms. International Journal of Pharmaceutical Erudition 1(4): 1-15.
Parmin, P., Suarayasa, K., & Wandira, B. A. (2020). Relationship between quality of service with patient loyality at general polyclinic of kamonji public health center. International Journal of Health & Medical Sciences, 3(1), 86-91. https://doi.org/10.31295/ijhms.v3n1.157
Suryasa, W., Sudipa, I. N., Puspani, I. A. M., & Netra, I. (2019). Towards a Change of Emotion in Translation of Kṛṣṇa Text. Journal of Advanced Research in Dynamical and Control Systems, 11(2), 1221-1231.
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