Validasi proses merupakan salah satu bagian yang termasuk dalammanajemen risiko. Validasi proses dilakukan bertujuan untuk menjamin prosesproduksi yang meliputi seluruh proses pengolahan sampai pengemasan akanmenghasilkan produk yang berkualitas dan bermutu sesuai acuan. Validasi prosesproduk tablet placebo “A” dilakukan karena adanya perubahan spesifikasi padaproduk. Tujuan dari penulisan ini adalah memahami prosedur validasi proses danparameter kritis dari pembuatan produk tablet placebo “A”. Pelaksanaan dilakukan diPT.Harsen Laboratories pada periode Agustus – Oktober 2020. Pembuatanprotokol validasi proses, kemudian melakukan validasi proses terhadap 3 batchpertama produksi rutin kemudian mengambil data dan mengolah data kedalambentuk laporan validasi proses. Prosedur validasi proses pembuatan produk tabletplacebo “A” dimulai dari pembuatan protokol validasi proses produk tablet placebo“A” kemudian juga membuat lembar kerja kemudian masuk ke tahap validasiproses dimulai dari proses granulasi. Proses granulasi dibagi menjadi 3 tahap prosesyakni pencampuran awal, pengeringan dan pengayakan serta pencampuran akhir.Setelah tahap granulasi dilanjutkan proses pencetakan tablet yang kemudiandilakukan evaluasi tablet yang telah tercetak. Pada tahap validasi proses jugamengisi lembar kerja yang digunakan untuk pembuatan laporan validasi prosesproduk tablet placebo “A”. Parameter kritis pada validasi proses pembuatanproduk tablet placebo “A” ialah susut pengeringan, pemerian, dan keseragamankandungan pada proses granulasi. Pemerian, bobot rata-rata, waktu hancur,kekerasan, diameter, ketebalan, kerapuhan, kadar, keragaman bobot pada prosespencetakan. Pemerian, bobot rata-rata, waktu hancur, diameter dan ketebalan padaproses penyalutan.

---

Process validation is one of the parts included in risk management. Process

validation is carried out to ensure the production process covering the entire

processing process until packaging will produce quality products and quality

according to the reference. Process validation of placebo tablet product "A" is done

because of the change in specifications on the product. The purpose of this writing

is to understand the process validation procedures and critical parameters of the

creation of placebo tablet products "A". The implementation is carried out at PT.

Harsen Laboratories in the period August – October 2020. Creating a process

validation protocol, then doing process validation on the first 3 batches of routine

production then taking the data and processing the data into the form of a process

validation report. The validation procedure of placebo tablet product creation

process "A" starts from the creation of placebo tablet product process validation

protocol "A" then also creates a worksheet and then goes to the validation stage of

the process starting from the granulation process. The granulation process is divided

into 3 stages of the process namely initial mixing, drying and sifting as well as final

mixing. After the granulation stage is continued the process of printing tablets

which is then evaluated tablets that have been printed. At the process validation

stage also fills in the worksheet used to create the placebo tablet product process

validation report "A". Critical parameters in the process validation making placebo

tablet products "A" is the shrinking drying, description and uniformity of the

content in the granulation process. Description, average weight, crushed time,

hardness, diameter, thickness, fragility, content, diversity of weights in the printing

process. average weight, crushed time, diameter and thickness in thelution process.