Sesi Semakan dan Penilaian Proses Permohonan dan Kelulusan Good Manufacturing Practices (GMP)


Good Manufacturing Practices (GMP) in Pharmaceutical Industry

Sesi produktif bersama National Pharmaceutical Regulatory Agency (NPRA) telah diadakan bagi meneliti keseluruhan proses permohonan dan kelulusan Pensijilan Amalan Perkilangan Baik (GMP), yang merupakan antara keperluan awal yang wajib dipatuhi oleh pihak industri sebelum sesuatu produk boleh diluluskan untuk pasaran.

Fokus utama sesi ini adalah untuk mengenal pasti tempoh masa yang terlibat bermula dari permohonan GMP melalui sistem QUEST3+, penilaian dokumentasi, pelaksanaan audit ke atas fasiliti pengilangan, sehinggalah proses kelulusan akhir diberikan.

Hasil perbincangan mendapati bahawa proses permohonan dan penilaian GMP yang dilaksanakan secara fizikal dan manual mengambil masa yang agak panjang sehingga 12 bulan bagi produk import dan sekitar 6 bulan bagi produk tempatan.

Perbincangan turut meneliti aspek-aspek yang boleh ditambah baik dalam usaha mempertingkat kecekapan penyampaian fungsi kawal selia oleh pihak NPRA, selari dengan aspirasi untuk mempercepat akses produk ke pasaran tanpa menjejaskan keselamatan dan kualiti.

Quick Share Links

By Media MPC August 1, 2025
Seminar Pelaksanaan Langkah-Langkah Kecekapan Tenaga di Premis Kerajaan pada 28 Julai 2025 di Hotel Sama-Sama, KLIA telah menghimpunkan perwakilan daripada semua kementerian dan agensi bagi memperkukuh pelaksanaan langkah kecekapan tenaga tanpa kos, selaras dengan arahan Pejabat Ketua Setiausaha Negara. Antara outcome utama termasuk penyeragaman pelabelan Building Energy Intensity (BEI) bagi bangunan kerajaan sebagai asas penambahbaikan kecekapan tenaga, yang secara langsung menyumbang ke arah penurunan Energy Intensity (EI) negara dalam penarafan World Competitiveness Ranking (WCR). Seminar ini turut berperanan sebagai platform penjajaran strategik dasar ke arah sektor awam yang lebih mampan, cekap tenaga dan berdaya saing. #EEProductivity #GREENProductivity
By Nexus MPC July 30, 2025
The Machinery & Equipment Productivity Nexus (MEPN) successfully convened its Governing Committee (NGC) Meeting Bil. 2/2025, chaired by the newly appointed MEPN Champion, Mr. Tiong Khe Hock. The session brought together key stakeholders from the public and private sectors, including representatives from MIDF, MATRADE, MIDA, SIRIM, and SEDA. The meeting began with the presentation of the MEPN Strategic Framework by Mr. Tiong, providing an overarching view of the Nexus’ direction. This was followed by progress updates from the Working Group (WG) leaders, each outlining focused initiatives for 2025. WG1, focused on upskilling the SME workforce, presented its planned tracks on digitalisation, AI readiness, productivity, and the OPERI assessment tool. WG2, which is already in progress, reported on Project PINTAR, the upcoming IPS (Industry Productivity Specialist) Training, and nationwide outreach efforts. WG3 shared plans for targeted interventions under PINTAR to enable digital and ESG readiness among SMEs. Meanwhile, WG4 updated on its ongoing efforts, including the Global Supply Chain Excellence initiative, Risk to Resilience Workshops, THINK: M&E platform, and the Strategic Productivity Roadmap. In addition to strategic discussions and project updates, the committee also welcomed several new members, further enriching the diversity and depth of expertise within the Nexus. The meeting was marked by strong support and constructive feedback, with members expressing optimism about the progress made and showing clear enthusiasm to enhance coordination and collaboration among all stakeholders. The positive tone and forward-looking momentum reaffirmed MEPN’s role as a national platform to drive productivity transformation across the Machinery & Equipment sector.
By Nexus MPC July 29, 2025
MEPN conducted an online briefing with DSA Dynamics (M) Sdn. Bhd. as part of the ongoing Project Pintar initiatives. The session served to introduce the objectives and framework of Project Pintar, while engaging the company in discussions on potential productivity improvement strategies tailored to their operations. This engagement reflects MEPN’s commitment to fostering collaboration with industry players in driving productivity growth and operational excellence within the machinery and equipment (M&E) ecosystem.
By Nexus MPC July 29, 2025
Program ini bertujuan mengenal pasti keperluan dan jurang pematuhan yang dihadapi oleh pengusaha akuakultur di peringkat lapangan, khususnya dalam aspek pensijilan seperti MyGAP, FQC dan MyGMP, serta keperluan kepada ladang moden untuk mematuhi zoning, dokumentasi dan penggunaan teknologi. Perbincangan turut merangkumi bagaimana teknologi Internet of Things (IoT) dan Kecerdasan Buatan (AI) dapat dimanfaatkan sepenuhnya bagi tujuan pemantauan real-time dan automasi proses. Penggunaan teknologi ini dijangka dapat meningkatkan keberkesanan pengurusan, mengurangkan kebergantungan kepada tenaga kerja manual dan menyokong kelestarian operasi akuakultur. Sebagai langkah ke hadapan, cadangan mewujudkan lorong khas Kebenaran Merancang (KM) bagi sektor pertanian akan dikemukakan untuk mempercepatkan proses pembinaan ladang moden. Sesi lanjutan bersama Jabatan Perikanan (DOF) akan dilaksanakan bagi meneliti ruang penambahbaikan proses pensijilan termasuk dokumentasi, tempoh kelulusan dan pembaharuan lesen. Di samping itu, insentif kecekapan tenaga akan diperluas kepada pengusaha akuakultur yang melabur dalam sistem pintar dan peralatan cekap tenaga. Sesi teknikal bersama SEDA dan Jabatan Perikanan akan diadakan untuk mengenal pasti skim sokongan yang sesuai termasuk bantuan teknikal, pensijilan tenaga dan akses kepada pembiayaan hijau.
By Nexus MPC July 28, 2025
MEPN successfully convened its Steering Committee Meeting Bil. 2/2025 focused on strengthening strategic alignment ahead of the upcoming Nexus Governing Committee Meeting. Key members and Working Group leads discussed progress updates and refined 2025 plans to ensure synergy across MEPN initiatives—ranging from workforce development and productivity enhancement to technology adoption and local supply chain strengthening. The meeting underscored the importance of cross-sector collaboration and outcome-driven planning to drive measurable impact in the machinery and equipment ecosystem. The deliberations served to reinforce MEPN’s role as a national productivity enabler, aligning efforts with broader economic and industrial aspirations.
By Nexus MPC July 28, 2025
The Chemical Productivity Nexus (CPN) convened a strategic meeting with HRDCorp to advance the implementation of the UNECE-ADR Dangerous Goods Safety Adviser (DGSA) programme. In this session, HRDCorp announced the approval of a Special Grant application to support the training and certification of approximately 45 Safety and Health Officers (SHOs) registered with the Department of Occupational Safety and Health (DOSH). This targeted funding will enhance accessibility for SMEs by covering critical expenses such as training fees, certification costs, and logistical support. The initiative complements the progress made to date, where 26 professionals from the chemical industry and relevant regulatory bodies have successfully attained DGSA certification through this internationally recognized programme. It also reflects Malaysia’s broader commitment to developing a safety-driven and competent workforce, particularly in the handling and transport of dangerous goods. As a next step, CPN will engage with the appointed DGSA Training Provider to finalize training arrangements and ensure alignment with HRDCorp’s grant requirements, reinforcing the consistent nationwide adoption of UNECE-ADR standards across the chemical sector.
By Nexus MPC July 28, 2025
The Aerospace Productivity Nexus (AeroPN) Tech-Up Financing Coordination Meeting gathered key agencies and industry leaders at MPC KL to align efforts in boosting aerospace productivity and financing. Deputy Director of MPC YBrs. Dr. Mazrina Mohamed Ibramsah opened the session, followed by AeroPN Champion Mr. Naguib Mohd Nor’s briefing on the AeroPN program and MITI’s financing initiatives. Micron Concept CEO Mr. Vee Hong presented the company’s aerospace project, with updates on its funding status. The meeting also featured a multi-agency discussion involving MPC, MTDC, MBSB, MIDF, MITI, and BNM on achieving national goals under NIMP, MAB, and WCR. The session concluded with renewed commitment from all parties to work together in accelerating the growth and global competitiveness of Malaysia’s aerospace sector.
By Nexus MPC July 28, 2025
Tarikh: 28 Julai 2025, Isnin Masa: 10 pagi Platform: Microsoft Teams Sesi ini bertujuan untuk meneroka peranan AKIE Group, sebuah francaisor yang komited dalam memperkasakan usahawan burger melalui pelaksanaan program keusahawanan di negeri Pahang. Syarikat ini menyokong 50 usahawan dari Pahang dan Putrajaya dengan membekalkan daging burger sejuk beku secara konsisten. Namun begitu, syarikat turut berdepan dengan cabaran utama termasuk isu logistik, kekurangan tenaga kerja, serta prestasi jualan yang tidak konsisten. Hasil daripada sesi perbincangan ini, RFBPN akan melaksanaan Program AI Produktiviti yang dirangka khusus untuk para usahawan di bawah naungan AKIE Group. Program ini bertujuan membantu usahawan memanfaatkan teknologi digital, terutamanya dalam aspek penghasilan kandungan promosi serta meningkatkan keberkesanan pelaporan prestasi perniagaan. Pendekatan ini bukan sahaja dijangka meningkatkan produktiviti dan kecekapan operasi, malah berpotensi memperkukuh daya saing usahawan burger dalam pasaran makanan yang semakin kompetitif dan dinamik.
Show More